MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 02/14/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following information was reported to gore: in an article titled ¿midterm results of a japanese prospective multicenter registry of heparin-bonded expanded polytetrafluoroethylene grafts for above-the-knee femoropopliteal bypass¿ it states the following: a prospective, multicenter, non-randomized study reviewed limbs undergoing akb with hb-eptfe graft for femoropopliteal lesion in 20 japanese institutions between july 2014 and october 2017.Primary efficacy endpoints were primary, primary assisted, and secondary graft patency.Safety endpoints included any major adverse limb event and perioperative mortality.During the study period, 120 limbs of 113 patients (mean age, 72.7 years) underwent akb with hb-eptfe grafts.A total of 45 patients (37.5%) had critical limb ischemia and 17 (15.0%) were on hemodialysis (hd).Median duration of follow-up was 16 months (range, 1¿36 months).Estimated 1- and 2-year primary, primary assisted, and secondary graft patency rates were 89.4% and 82.7%, 89.4% and 87.2%, and 94.7% and 92.5%, respectively.On univariate analysis of 2-year primary graft patency, having 3 run-off vessels, cuffed distal anastomoses, no coronary artery disease, and no chronic kidney disease requiring hd were significantly associated with favorable patency.Reintervention was performed in 11 of the 120 limbs.Three limbs required secondary evt for stenosis of the proximal anastomosis.In 2 of these 3 limbs, only balloon angioplasty was performed, and a covered stent with a heparin bioactive surface was placed in the remaining case.In 8 of the 11 limbs, a secondary intervention to treat graft thrombosis was required through open thrombectomy (n=5), open thrombectomy with patch or angioplasty of the proximal anastomosis (n=2), or redo bypass surgery using hb-eptfe graft (n=1).A total of 12 graft occlusions were observed during the follow-up period.At the onset of graft occlusion, 3 patients had mild-to moderate intermittent claudication, which was treated using anti-thrombotic medication only.One patient with graft occlusion and deterioration of general condition due to heart failure died after major amputation without any vascular reconstruction.Major amputation was performed in 2 patients (1.8%) in the follow-up period, and 8 patients (7.0%) died.Cause of death was cardiac event in 4 patients, fatal sepsis in 3, and cancer in 1.There were 2 patients (1.8%) with wound infection and 2 (1.8%) with seroma.Prosthetic graft infection occurred in 1 patient (0.9%).In that patient, fluid collection was detected around the implanted graft and the anastomotic site, and methicillin-resistant staphylococcus aureus was detected in both the proximal and peripheral areas of the wound 2 weeks after bypass surgery.The infection was controlled by tube drainage, daily irrigation, and antibiotic treatment without graft excision.This parent case addresses the following: one prosthetic graft infection.

Event Description

The following information was reported to gore: in an article titled ¿midterm results of a japanese prospective multicenter registry of heparin-bonded expanded polytetrafluoroethylene grafts for above-the-knee femoropopliteal bypass¿ it states the following: a prospective, multicenter, non-randomized study reviewed limbs undergoing akb with hb-eptfe graft for femoropopliteal lesion in 20 japanese institutions between july 2014 and october 2017.Primary efficacy endpoints were primary, primary assisted, and secondary graft patency.Safety endpoints included any major adverse limb event and perioperative mortality.During the study period, 120 limbs of 113 patients (mean age, 72.7 years) underwent akb with hb-eptfe grafts.A total of 45 patients (37.5%) had critical limb ischemia and 17 (15.0%) were on hemodialysis (hd).Median duration of follow-up was 16 months (range, 1¿36 months).Estimated 1- and 2-year primary, primary assisted, and secondary graft patency rates were 89.4% and 82.7%, 89.4% and 87.2%, and 94.7% and 92.5%, respectively.On univariate analysis of 2-year primary graft patency, having 3 run-off vessels, cuffed distal anastomoses, no coronary artery disease, and no chronic kidney disease requiring hd were significantly associated with favorable patency.Reintervention was performed in 11 of the 120 limbs.Three limbs required secondary evt for stenosis of the proximal anastomosis.In 2 of these 3 limbs, only balloon angioplasty was performed, and a covered stent with a heparin bioactive surface was placed in the remaining case.In 8 of the 11 limbs, a secondary intervention to treat graft thrombosis was required through open thrombectomy (n=5), open thrombectomy with patch or angioplasty of the proximal anastomosis (n=2), or redo bypass surgery using hb-eptfe graft (n=1).A total of 12 graft occlusions were observed during the follow-up period.At the onset of graft occlusion, 3 patients had mild-to moderate intermittent claudication, which was treated using anti-thrombotic medication only.One patient with graft occlusion and deterioration of general condition due to heart failure died after major amputation without any vascular reconstruction.Major amputation was performed in 2 patients ((b)(4)) in the follow-up period, and 8 patients ((b)(4)) died.Cause of death was cardiac event in 4 patients, fatal sepsis in 3, and cancer in 1.There were 2 patients ((b)(4)) with wound infection and 2 ((b)(4)) with seroma.Prosthetic graft infection occurred in 1 patient ((b)(4)).In that patient, fluid collection was detected around the implanted graft and the anastomotic site, and methicillin-resistant staphylococcus aureus was detected in both the proximal and peripheral areas of the wound 2 weeks after bypass surgery.The infection was controlled by tube drainage, daily irrigation, and antibiotic treatment without graft excision.This parent case addresses the following: one prosthetic graft infection.

Manufacturer Narrative

Shibutani s, obara h, matsubara k, toya n, isogai n, ogino h, watada s, asami a, kudo t, kanaoka y, fujimura n, harada h, uchiyama h, sato y, ohki t; japanese bypass registry group, tokyo, japan.Midterm results of a japanese prospective multicenter registry of heparin-bonded expanded polytetrafluoroethylene grafts for above-the-knee femoropopliteal bypass.Circ j.2020 feb 25;84(3):501-508.Doi: 10.1253/circj.Cj-19-0908.Epub 2020 feb 14.Pmid: 32062636.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10480473
• MDR Text Key: 214406325
• Report Number: 2017233-2020-01204
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR