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

Device Problem Material Rupture (1546)

Patient Problem Wound Dehiscence (1154)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

The age of patient 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 distal anastomosis with redo anastomosis, which required surgical revision.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10127074
• MDR Text Key: 195242522
• Report Number: 2017233-2020-00410
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR