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

Model Number 25057

Device Problem Delamination (2904)

Patient Problem No Information (3190)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

The graft external layer delaminated because the doctor could not use the tunneler connection.

Manufacturer Narrative

The graft was not returned for evaluation, therefore, and investigation of the actual sample was not able to be performed.The report stated that the graft was received without the graft deployment system (gds) components.Unlike other flixene graft models that the surgeon has implanted in the past, atrium does offer this particular graft model with a gds.According to the field report the graft delaminated.The delamination issue could be contributed to the fact that the flixene graft was tunneled through a tight tunneling site without the use of the tunneling sheath.A situation as such could increase the tunneling friction and cause the graft to delaminate.The device history records for the reported complaint were reviewed and found to have met all specifications.

Manufacturer Narrative

The graft was not returned for evaluation, therefore, an investigation of the actual sample was not able to be performed.The report stated that the graft was received without the graft deployment system (gds) components.Unlike other flixene graft models that the surgeon has implanted in the past, atrium does not offer this particular graft model with a gds.According to the field report the graft delaminated.The delamination issue could be contributed to the fact that the flixene graft was tunneled through a tight tunneling site without the use of the tunneling sheath.A situation as such could increase the tunneling friction and cause the graft to delaminate.The device history records for the reported complaint were reviewed and found to have met all specifications.

• Brand Name: FLIXENE GRAFT
• Type of Device: PROSTHESIS, VASCUALR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5129206
• MDR Text Key: 27521896
• Report Number: 1219977-2015-00286
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K060124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Model Number: 25057
• Device Catalogue Number: 25057
• Device Lot Number: AJ27804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2010
• 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: 50 YR
• Patient Weight: 73