ZENHALE lots recalled due to device malfunction

Background: There is paucity of knowledge regarding the spectrum of neurothrombectomy(NT) device-related complications. Objective: To report the characteristics and proportions of reported adverse-events(AE) related to NT devices used in endovascular treatment of acute ischemic stroke (AIS). Methods: We identified NT device-related AE reported by voluntary sources, user facility reports, and distributor and manufacturer reports to the Manufacturer and User Facility Device Experience Database(MAUDE) from the year 2004 through 2012 to identify patients. Frequency of specific reported AE and associated factors were extracted from the “event description” on the three NT devices currently in use for AIS treatment -Merci Retriever, Penumbra System, and Solitaire-FR stentriever. Results: A total of 706 reported NT device-related AEs were identified with a continual increase in reporting rate since 2004. Of the 706, device malfunction (kink, twist, difficult advancing, fracture, or retention) was the most common reported complication(56%), followed by hemorrhages(23%), dissection(6.8%), vasospasm(6.2%), and distal embolism(2.7%). Intra-arterial(IA) thrombolytic was used in 70%(111/159), intravenous(IV) thrombolytic in 16%, and both IA and IV in 13% of the reported cases. Middle cerebral artery(MCA) was involved in 56%(220/392), internal carotid artery(ICA) in 16 %, and both MCA and ICA in about 21% of cases where the occluded vessel was reported. Multiple devices were used in majority(71%) of reported cases(n=564). The first “pass”(recanalization-attempt) was associated with 34% of reported adverse event per-device(n= 119), 2-passes(29%), and 3-passes(28%). Recanalization was complete in 52 %(266/513) reported cases, and partial in 14%(71/513). Patients’ condition was unchanged in 63%(220/349), worsened in 29%(101/349), and improved in 8%(28/349) of reported cases. Twenty three percent(77/342) mortality was reported among those patients whose final outcome was known and reported. Conclusions: Reports of NT device-related AE have significantly increased over the last 8 years. Proportionally higher-rates of reported device malfunction do not necessarily represent adverse patient outcomes.

Download Full-text

Hilar control during laparoscopic donor nephrectomy: Practice patterns in Canada

Canadian Urological Association Journal ◽

10.5489/cuaj.4490 ◽

2017 ◽

Vol 11 (10) ◽

pp. 321-4 ◽

Cited By ~ 1

Author(s):

Thomas B. McGregor ◽

Premal Patel ◽

Gabriel Chan ◽

Alp Sener

Keyword(s):

Renal Artery ◽

Online Survey ◽

Response Rate ◽

Donor Nephrectomy ◽

Vascular Control ◽

Laparoscopic Donor Nephrectomy ◽

Open Conversion ◽

Device Malfunction ◽

Poor Outcomes ◽

Emergent Laparotomy

Introduction: In recent years, the method of vascular control during laparoscopic donor nephrectomy (LDN) has come under scrutiny due to catastrophic consequences of a device failure. This study sought to examine the surgical preferences of Canadian donor surgeons with regards to vascular control and their perception on the safety of these modalities. We also surveyed the experience with device malfunction and their subsequent management during LDN.Methods: An online survey was sent out to donor surgeons registered with the Canadian Society of Transplantation. Surveys were anonymous and voluntary. Descriptive statistics were used to analyze the collected responses. Recollection of the sequelae and outcomes from device malfunction were also queried.Results: Twenty-eight of 37 surgeons (76% response rate) responded to the survey. At least one surgeon from every institution in Canada performing LDN responded to the survey. Laparoscopic stapler is the most commonly used device for securing the renal artery (61%) and renal vein (67%). Overall, surgeons felt the stapler was the safest method of securing the renal artery. Stapler misfire and clip slippage were reported by eight (28.5%) and 1 2 (43%) surgeons, respectively. Most cases were salvageable: laparoscopically (30%), open conversion (30%), and by hand port (5%). Slippage of a plastic locking clip resulted in one emergent laparotomy on POD#1 and one stapler misfire was converted to open resulting in donor death.Conclusions: Although rare, hemorrhagic complications can occur from device malfunction resulting in poor outcomes for healthy volunteers undergoing LDN. Surgeons need to remain vigilant when selecting the appropriate modality for vascular control.

Download Full-text