MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE VASCULAR GRAFT

Device Problem Delamination (2904)

Patient Problem No Information (3190)

Event Date 04/27/2016

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

Report received stated that the doctor had a flixene graft that had delaminated and had to be explanted.No further information was provided.

Manufacturer Narrative

The lot number was not provided so a device history record could not be performed and the graft was not returned therefore the root cause could not be identified.An attempt was made to obtain additional information regarding the complaint and the complainant did not want to provide any further details regarding the event.All graft lots undergo testing prior to release per internal quality procedures.These tests include the following: longitudinal tensile strength, radial tensile strength, water entry pressure, suture retention, 100% visual and tactile inspection.All test reports are verified to have passed test requirements prior to lot release.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: FLIXENE VASCULAR 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: 5700077
• MDR Text Key: 46566775
• Report Number: 1219977-2016-00104
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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