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

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Received an article published in the scientific world journal titled "modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review." according to the study, a hero graft was placed in eligible patients who were considered to be catheter dependent for life.By combining the hero graft system with a flixene graft, patients were able to remove catheters sooner or avoid placement as they could undergo cannulation for hemodialysis the next day.Per the study, two grafts failed due to poor inflow.

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.According to the article, by making use of this novel technique, twenty-one patients over a two-year period with various forms of central venous stenosis, catheter dependence, or failing existing arteriovenous access have been successfully converted to stable long term noncatheter based upper extremity access.The author of the article was contacted and replied that they did not have any problems with the use of flixene.

• Brand Name: FLIXENE GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4004726
• MDR Text Key: 4775511
• Report Number: 1219977-2014-00224
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• 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: 07/04/2014
• 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
• Treatment: HERO GRAFT
• Patient Outcome(s): Required Intervention