MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number 25137

Device Problem Degraded (1153)

Patient Problem Unspecified Infection (1930)

Event Date 02/06/2015

Event Type  Injury  

Event Description

Patient was admitted to hospital with infection and graft was explanted.During the explant it was observed that the outer layer of the graft had separated from the inner layer.

Manufacturer Narrative

The graft was not returned for evaluation.Therefore, the root cause of this occurrence could not be investigated.It is possible that a eptfe vascular graft could become infected within a few weeks of implantation as a result of a microbial contamination, wound infection around the implantation site, or the introduction of bacteria during dialysis treatment.The instruction for use (ifu) in the adverse reactions section warns against graft infection.Vascular grafts are made from expanded ptfe material, which consists of interspaced nodes interconnected by elongated fibrils.The spaces between the fibrils are large enough to promote tissue ingrowth, and enhance cell endothelization to the substrate layers of the graft.Tissue penetration occurs almost within two weeks of the initial implantation of the graft.At two week, there could be a complete cellular infiltration through the entire wall of the grafts.This infiltration could create a significant bond within the layers.The bond strength between the tissues and the layers of the graft, especially the outer of the graft, could impact it and cause it to delaminate when the graft is being revised.Graft cover layers may become separated from the base layer if the use of a 1:1 sized bullet tip was used for tunneling the graft.The outside diameter of a 6mm flixene graft is greater than 7mm.If a 6mm tunneling tip was used to tunnel this graft, a tight tunneling site could have been occurred causing an increased tunneling force.An increased tunneling force could cause the external layer to separate from the rest of the graft.The device history and sterilization records were reviewed.The product was found to have met all specifications.

• Brand Name: ADVANTA FLIXENE GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: lori gosselin, sr. coord ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4567317
• MDR Text Key: 5549316
• Report Number: 1219977-2015-00053
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2019
• Device Model Number: 25137
• Device Catalogue Number: 25137
• Device Lot Number: 209091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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: 67 YR