Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

2021 ◽  
pp. 194589242110356
Author(s):  
Viraj N. Shah ◽  
Luke J. Pasick ◽  
Daniel A. Benito ◽  
Michael K. Ghiam ◽  
Christine D’Aguillo
Keyword(s):  
Adverse Events ◽  
Mometasone Furoate ◽  
Sinus Surgery ◽  
Comprehensive Understanding ◽  
Outflow Obstruction ◽  
The Us ◽  
User Facility ◽  
Drug Eluting ◽  
Headache Pain ◽  
Common Device

Background Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Objective To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Methods The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. Results After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). Conclusions PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.

Adverse Events Associated With Corticosteroid-Eluting Sinus Stents: A MAUDE Database Analysis

2021 ◽  
pp. 019459982110069
Author(s):  
Vishal Narwani ◽  
Sina J. Torabi ◽  
David A. Kasle ◽  
Rahul A. Patel ◽  
Michael Z. Lerner ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Fungal Infection ◽  
Postoperative Infection ◽  
Cross Sectional Study ◽  
Common Adverse Event ◽  
Sinus Surgery ◽  
Cross Sectional ◽  
The Us ◽  
User Facility

Objective Corticosteroid-eluting stents (CESs) are increasingly used after endoscopic sinus surgery to reduce the need for revision surgery, but their use is not without risks. The objective of this study is to describe adverse events related to CESs. Study Design Retrospective cross-sectional study. Setting The US Food and Drug Administration’s MAUDE database (2011-2020; Manufacturer and User Facility Device Experience). Methods The MAUDE database was queried for reports of adverse events involving the use of CESs approved by the Food and Drug Administration, including Propel, Propel Mini, Propel Contour, and Sinuva (Intersect ENT). Results There were 28 reported adverse events in total, with all events being related to the Propel family of stents and none related to Sinuva stents. Overall, 22 were categorized as patient-related adverse events and 6 as device-related events. The most common adverse event was related to postoperative infection, accounting for 39% (n = 11) of all complications. Four of these patients developed periorbital cellulitis, and 5 developed a fungal infection. The second-most common adverse event was migration of the stent, representing 21% of all complications (n = 6). Overall, 8 patients (29%) in our cohort required reintervention in the operating room, with subsequent removal of the CES. Conclusion The most commonly reported adverse events were postoperative infection, including multiple cases of fungal infection, followed by migration of the stent. An increased awareness of the complications associated with CESs can be used to better inform patients during the consenting process as well as surgeons in their surgical decision making.

scholarly journals Adverse Events Involving Hallux Metatarsophalangeal Joint Implants: Comprehensive Analysis of US Food and Drug Administration Data from 2010 to 2018

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0009
Author(s):  
Craig C. Akoh ◽  
Rishin J. Kadakia ◽  
Jie Chen ◽  
Young-uk Park ◽  
Hyong Nyun Kim ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Options ◽  
Metatarsophalangeal Joint ◽  
Long Term Effects ◽  
Modes Of Failure ◽  
The Us ◽  
User Facility ◽  
Joint Implants ◽  
Component Loosening

Category: Midfoot/Forefoot; Other Introduction/Purpose: The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is estimated to affect 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and salvage arthrodesis. Arthroplasty of the great toe MTPJ has evolved over the past several decades. The aims of this study were to examine the MAUDE database to determine reported adverse events for hallux MTPJ arthroplasty. Methods: The US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010-2018 to determine reported adverse events for approved implants. We recorded and categorized the type of adverse event and excluded duplicate reports and those extracted from already published literature. Results: Among 64 unique hallux MTPJ implant adverse events, the most common modes of failure were component loosening (34%), component fracture (9.4%), inflammation (9.4%), infection (14.1%), and allergic reaction (7.8%). In regards to implant type, synthetic implants (Cartiva) had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). The number of adverse events reported increased substantially after 2016. Conclusion: Our study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion and Ascension MGT implants. Given that the adverse events for hallux MTPJ implants are underreported, improved reporting mechanisms should be utilized to improve our understanding on long-term effects of various hallux MTPJ implants. [Table: see text]

scholarly journals Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

2021 ◽  
Vol 16 (2) ◽  
pp. 177-183
Author(s):  
Nitish Aggarwal ◽  
Robert Chow
Keyword(s):  
Adverse Events ◽  
Conservative Therapy ◽  
Neurogenic Claudication ◽  
Decompression Surgery ◽  
Randomized Controlled ◽  
The Us ◽  
User Facility ◽  
Interspinous Spacers ◽  
Lumbar Spinal ◽  
Lumbar Decompression Surgery

Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. Conclusions: Further studies such as randomized controlled trials are needed to validate the findings.

scholarly journals Linguistic validation of the simplified Chinese version of the US National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Cheng KKF ◽  
S. A. Mitchell ◽  
N. Chan ◽  
E. Ang ◽  
W. Tam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
A Priori ◽  
Cognitive Interviews ◽  
Simplified Chinese ◽  
Patient Reported ◽  
The Us ◽  
The Common ◽  
Response Choices

Abstract Background The aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore. Methods All 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available. Results A majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension. Conclusions PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

scholarly journals Adverse Events in Total Ankle Arthroplasty, Analysis of the FDA Medical and User Facility Device Experience Database

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0028
Author(s):  
Karim Mahmoud ◽  
Sreenivasulu Metikala ◽  
Kathryn O’Connor ◽  
Daniel Farber
Keyword(s):  
Adverse Events ◽  
Aseptic Loosening ◽  
Mandatory Reporting ◽  
Total Ankle Replacement ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthritis ◽  
Ankle Arthroplasty ◽  
Ankle Replacement ◽  
Mode Of Failure ◽  
User Facility

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement has become a popular treatment option for end stage ankle arthritis. Most of the reports of adverse events following total ankle replacement have been from high volume institutions and are subject to either observational or selection bias as well as potential under-reporting as they do not include the experience of community and lower volume centers and surgeons. The FDA’s Medical and User Facility Device Experience (MAUDE) Database provides a more complete scope of adverse events due to the mandatory reporting requirements by the FDA of implant manufactures. We reviewed the database to identify the common modes of failure and complications of total ankle implants Methods: We retrospectively reviewed reports of the MAUDE database from November 2011 to September 2018 regarding all total ankle implants. Each device in the MAUDE database is classified with a 3-letter code, we identified the 2 codes assigned to total ankle arthroplasty devices, and manually searched the FDA’s published Device Classification list for adverse events. All events were reviewed and classified. Data related to patient age or sex, surgeon, medical center location are not available in the database Results: We identified 1000 adverse reports in the period between November 2011 and September 2018. After exclusion of duplicate reports for single events or reports irrelevant to total ankle arthroplasty, a total of 697 adverse event reports were noted. The most common mode of failure was aseptic loosening (21%), followed by infection (16%), alignment and mechanical issues (instability, malalignment, malposition, stiffness, impingement) (15%), implantation issues (pin, screw or drill breakage, alignment guide problems) (9%), polyethylene related problems (wear, displaced or fractured implants) (7%), bony and soft tissue overgrowth (6%), and peri-prosthetic fractures (5%). Conclusion: Our analysis reveals that the most reported mode of failure was aseptic loosening followed by infection. However, it is notable that there are a significant number of issues with implant alignment and mechanics, complications during implantation and polyethylene component failure that are under-reported in the literature. Knowledge of these adverse events may help surgeons avoid similar complications as well as lead to improvement in component implantation and design

Abstract 17178: Adverse Events in Endovascular Robotic Assisted Procedures

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Naveen Kumar Sankaran ◽  
Sai Rakesh Rachakonda ◽  
Abraham Kocheril ◽  
Suraj Kapa ◽  
Thenkurussi Kesavadas
Keyword(s):  
Adverse Events ◽  
Radiation Exposure ◽  
Endovascular Procedures ◽  
Hemodynamic Instability ◽  
Patient Death ◽  
User Facility ◽  
Robotic Devices ◽  
Patient’S Outcome ◽  
Aneurysm Repair ◽  
The Impact

Introduction: Endovascular procedures are traditionally performed for a variety of indications. However, guidewire/catheter manipulation and hazardous radiation exposure are limitations to manual interventions. Thus, significant work has been done to develop robotic approaches to therapies. These devices have FDA clearance for performing procedures like cardiac arrhythmias, angioplasty, aneurysm repair and stenting etc. With the increasing usage of robotic assistance in endovascular procedures, it is essential to understand the adverse events that may occur. This study aims to provide an understanding of adverse events with currently available robotic systems. Methods: The analysis of adverse events is performed with the FDA MAUDE (Manufacturer and User Facility Device Experience) database. MAUDE database is a collection of reports on medical devices reported by manufacturers, distributors, users, volunteers. In case of occurrence of adverse events, FDA regulations requires that event to be reported for further investigation. Based on the impact of events on the patient’s outcome, the reported events were grouped into 3 categories death (patient death), injury (patient injury) or device malfunction. Results: A total of 71 different events were reported collectively for all the four robotic devices (Hansen Medical- 37, Corindus Inc.-27, Stereotaxis Inc.-5 & Catheter Robotics Inc.-2). The major adverse events included death and common injuries such as perforation, pseudo-aneurysm / blockage/ tamponade/ clot, blood pressure dropped or an effusion, or hemodynamic instability. The table summarizes the events by brand of system. Conclusions: While robotic approaches to intervention reflect a potentially useful means to improve outcomes of endovascular procedures by optimizing catheter manipulation with finer robotic motions or limiting radiation exposure, there are potentially significant risks. Whether these reflect higher or lower risk than traditional manual approaches requires randomized studies. Use of robotic technologies may present additional risks in light of potential malfunctions that occur from system errors that a human system may not be prone to. Future studies will be needed to better understand incremental benefit.

What is Being Reported About Vaginal “Lasers”?: An Examination of Adverse Events Reported to the Food and Drug Administration on Energy-Based Devices

2021 ◽  
Author(s):  
Linda Burkett ◽  
Pamela Moalli ◽  
Mary Ackenbom
Keyword(s):  
Adverse Events ◽  
Local Treatment ◽  
Safety Data ◽  
Co2 Lasers ◽  
Laser Technologies ◽  
Surgical Devices ◽  
Device Type ◽  
User Facility ◽  
Similar Risk ◽  
Sensation Loss

Abstract Background Description of energy-based genitourinary non-surgical devices (energy-based devices) safety data is outlined given their rapid adoption. Objectives To describe adverse events (AEs) for energy-based devices in the Manufacturer and User Facility Device Experience (MAUDE) database, and to compare to similar devices and other subspecialty applications. We hypothesized that products with genitourinary applications had similar AEs to dermatologic or general surgery applications. Methods Reed Tech™ Navigator compiled AE reports for all registered energy-based devices. Individual AE reports associated with 1) non-ablative, 2) fractionated, 3) unfractionated 4) radiofrequency, and 5) hybrid laser technologies were categorized. AE characteristics were compared among genitourinary applications (n=39) and other subspecialty applications within the same devices (n=79). Results Eighteen manufacturers were identified, which collectively manufacture 43 products with genitourinary applications. Thirty-nine genitourinary AEs were reported and isolated to 6 manufacturers with 11 products, of which 82% (n=32) were injuries, 15% (n=6) were device malfunction, and 3% (n=1) related to improper maintenance. Local treatment reactions were the most commonly reported injury (62%, n=21). AEs varied by device type with CO2 lasers having more burns and radiofrequency devices having higher rates of sensation loss. When comparing similar technology types, genitourinary energy-based devices had the least AE reports per device in MAUDE database. Conclusions AEs were reported on a quarter of the products currently available, and most were local treatment reactions. The reporting of AEs is equal to that of other subspecialties suggesting similar risk profiles. Improved reporting is needed to fully evaluate the safety of individual energy-based devices.

scholarly journals Hypersensitivity Reaction in the US Food and Drug Administration–Approved Second-Generation Drug-Eluting Stents

Circulation ◽  
2015 ◽  
Vol 131 (3) ◽  
pp. 322-324 ◽  
Author(s):  
Fumiyuki Otsuka ◽  
Kazuyuki Yahagi ◽  
Elena Ladich ◽  
Robert Kutys ◽  
Russell Alexander ◽  
...  
Keyword(s):  
Hypersensitivity Reaction ◽  
Drug Administration ◽  
Second Generation ◽  
Food And Drug Administration ◽  
Drug Eluting Stents ◽  
The Us ◽  
Drug Eluting
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