MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Injury (2348)

Event Date 12/15/2014

Event Type  Injury  

Event Description

Surgeon mentioned that during an implantation of a flixene graft for dialysis a patient developed edema.Graft was explanted and during the explant it caused damage to the patient arm which had to be skin grafted.

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.The complainant was contacted but had no further details to provide.It was stated that the graft in this case was implanted without issue.The next morning the patient reported edema.The graft eventually had to be explanted.Edema is a general response of the body to injury or inflammation.Edema can be isolated to a small area or affect the entire body.Medications, infections, surgical procedures and many medical problems can cause edema.Edema results whenever small blood vessels become "leaky" and release fluid into nearby tissues.The extra fluid accumulates, causing the tissue to swell.Edema is a normal response of the body to inflammation or injury (such as injury to tissues caused by surgical procedures.).

• Brand Name: FLIXENE GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645366
• MDR Report Key: 4454258
• MDR Text Key: 5426400
• Report Number: 1219977-2015-00029
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2015
• 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