MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

The age and gender sections were completed with the provided mean age and mean gender of the article.The date of event was completed with the date when the article was accepted as individual date of event was not stated in article.Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass¿, published by gabriele piffaretti et al, within the journal of vascular surgery.

Event Description

Within the article ¿results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass¿, published by gabriele piffaretti et al, within the journal of vascular surgery, the article indicates the following: the aim of the study was to retrospectively analyze early and follow-up results of above-the-knee femoropopliteal bypasses (akb) performed with a bioactive heparin-bonded expanded polytetrafluoroethylene (hb-eptfe) graft (gore propaten) in patients with peripheral arterial obstructive disease in a multicentric retrospective registry.During a 14-year period ending in march 2016, an hb-eptfe graft was used in 1401 interventions performed for peripheral arterial obstructive disease.A post hoc analysis of the database was performed to identify 364 (25.9%) patients who underwent akb.Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations, reinterventions, and the occurrence of major local and systemic complications.Follow-up results were analyzed by life-table analysis in terms of primary and secondary graft patency, assisted primary patency, limb preservation, and amputation-free survival.There was one dehiscence of the inguinal surgical wound with secondary closure.

Manufacturer Narrative

Corrected data: additional manufacturer narrative: input from the gore product specialist and the gore office of medical affairs determined this event is not device related.Therefore this event is not reportable to the fda and is retracted.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10127103
• MDR Text Key: 195242752
• Report Number: 2017233-2020-00411
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR