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 03/26/2015

Event Type  Injury  

Event Description

We report the delamination of an infected flixene vascular ptfe graft that caused the outer layer to become inadvertently left in the pt's arm during planned removal of an infected, causing recurrent foreign body granuloma formation, necessitating reoperation.The pt is a (b)(6) year old woman with chronic renal failure, dialysis dependent.She had been receiving chronic maintenance hemodialysis via a flixene ptfe vascular graft.The graft was implanted on (b)(6) 2012 and the ifu were followed.The graft was used for dialysis until it became infected and had to be removed on (b)(6) 2014.During the removal procedure the surgeon observed extensive delamination of the infected flixene graft that made complete removal difficult because the outer layer remained adherent to the tissues and the inner layers slipped out freely.Long incisions were made the entire length of the arterial and venous limbs of the graft to try to dissect free the entire graft.The pt presented with fluctuant masses of the axilla and the upper arm on (b)(6) 2014.They were explored and found to be granulomas with associated seromas.They were drained, cultured, and biopsied and found to be foreign body granulomas and cultures were negative.The wounds healed but the axillary and upper arm masses recurred.She underwent excision of the masses including margins of normal surrounding tissue on (b)(6) 2015.The findings were thin membranes of ptfe along with coagulated seroma and granulomatous tissue.The ptfe was returned to the mfr for study.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PTFE VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL; hudson NH
• MDR Report Key: 4679882
• MDR Text Key: 5689243
• Report Number: 4679882
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• 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: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2015
• Distributor Facility Aware Date: 03/26/2015
• Device Age: 2 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/30/2015
• 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