MAUDE Adverse Event Report: ATRIUM MEDICAL FLIXENE VASCULAR GRAFT; PTFE VASCULAR GRAFT

Model Number 25061

Device Problems Entrapment of Device (1212); Delamination (2904)

Patient Problems Foreign Body Reaction (1868); Foreign Body In Patient (2687)

Event Date 05/14/2015

Event Type  Injury  

Event Description

This is a follow-up report on the (b)(6) woman with chronic kidney failure dialysis dependent who had been receiving chronic maintenance hemodialysis via a flixene ptfe vascular graft.The graft was implanted on (b)(6) 2012.It was infected and had to be removed on (b)(6) 2014.At that time delamination of infected graft was observed that made to complete removal difficult as the outer layer remained adherent to the tissues and the inner layers slipped out freely.She experienced recurrent infection related to a suspected foreign body granuloma requiring reoperation on (b)(6) 2015.The granuloma was returned to the mfr but no ptfe was found within the specimen.The pt once again developed another infection that was suspected as being a granuloma.She underwent reoperation on (b)(6) 2015 where what appeared to be a ptfe granuloma was excised from the incision.Arrangements are being made for its analysis by the mfr.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PTFE VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL; hudson NH
• MDR Report Key: 4906218
• MDR Text Key: 6070914
• Report Number: 4906218
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Model Number: 25061
• Device Lot Number: AK3355130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2015
• Distributor Facility Aware Date: 05/14/2015
• Device Age: 4 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 43