MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PTFE FLIXENE GRADUATED WALL 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

Report received stated that the patient who had experienced recurrent infection related to a suspected foreign body granuloma developed another infection and underwent a reoperation on (b)(6) 2015 for what appeared to be a polytetrafluoroethylene (ptfe) granuloma that was excised from the incision.

Manufacturer Narrative

We are awaiting the return of the sample for investigation and will submit the follow-up report once the evaluation is completed.Previously related mdr 1219977-2015-00116.(b)(4).

Manufacturer Narrative

The hospital sent a segment of the explanted material to atrium to be examined.The explanted segment was placed by the medical center inside a capped container and then placed inside multiple bio-hazard and polybags.Upon receipt by atrium medical, the returned segment was taken out of the capped bio-hazard container and placed inside a biohood to be examined.The returned segment was completely covered with blood and biological tissues.The explanted segment was about 1.5" in diameter.The initial visual inspection could not determine the presence of eptfe material due to the presence of thick layers of tissues.The explanted segment was then sent out to an independent lab for further analysis.The lab found that microscopically, the sample consisted of epidermis/dermis and associated subcuticular tissue (i.E., skin).Within the dermis there was a focally extensive area of dense, bundled collagen deposition interpreted to likely represent an area of surgical wound healing (i.E., ('scarification').Within the subcutis there was a focally extensive area of fibrovascular tissue proliferation (i.E., ('granulation tissue') associated with a fibrinous surface.This observation was interpreted as consistent with what would be expected to be surrounding/interfacing with a vascular graft implant.There was no evidence of non biological material (e.G., ptfe graft).The lot history of the referenced graft was reviewed and it was found to have met all specifications.An infection two years after the procedure is not likely to be caused by the graft.The product is provided sterile to the user.The sterilization records were reviewed and the sterilization load was processed within specifications.Conclusion: clinically removed material from the previous site of a vascular graft was consistent with reactive fibrous connective tissue with no evidence of non-biological material (e.G., ptfe graft material).

• Brand Name: PTFE FLIXENE GRADUATED WALL GRAFT
• Type of Device: PTFE FLIXENE GRADUATED WALL GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051 4929
• Manufacturer Contact: lori gosselin ; 5 wentworth drive; hudson, NH 03051-4929 ; 6038645366
• MDR Report Key: 4903477
• MDR Text Key: 6829361
• Report Number: 1219977-2015-00178
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• 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: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: 25061
• Device Catalogue Number: 25061
• Device Lot Number: AK33551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2011
• 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: 29 YR
• Patient Weight: 43