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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

Published article 'comparison of propaten heparin-bonded vascular graft with distal anastomotic patch versus autogenous saphenous vein graft in tibial artery bypass' (jeremy kaisar, m.D.; aaron chen, m.D.; mathew cheung, m.D.; elias kfoury, m.D.; carlos bechara, m.D.And peter lin, m.D.; vascular 2018, vol.26(2) 117¿125; journals.Sagepub.Com/home/vas) was reviewed.The purpose of this study is to analyze experiences with tibial artery revascularization using heparin-bonded eptfe gore® propaten® vascular grafts with distal anastomotic patch and autogenous saphenous vein conduits.A retrospective review of a prospectively collected database was performed for all patients undergoing tibial artery bypass from january 2001 to june 2016 at two university-affiliated academic medical centers.The article reported on page 120 graft occlusion occurred in 17 propaten patients within 30 days of implant.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #unk.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10123503
• MDR Text Key: 194149161
• Report Number: 2017233-2020-00403
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: 73 YR