MAUDE Adverse Event Report: ATRIUM MEDICAL CORPROATION FLIXENE GRAFTS; PROSTHESIS, VASCULAR GRAFT

Device Problem Kinked (1339)

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

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Received an article titled: early outcomes of the intraluminal flow guard device for secondary renal access published in the journal of vascular access.The article discussed early patency and complications using the graft as an arteriovenous graft for use in complex renal access patients.Per the article, a graft in one of the patient's kinked.

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the article, the flixene intraluminal flow guard device provides an alternative to standard brachial-axillary grafts and brings similar early patency and complications profile.

• Brand Name: FLIXENE GRAFTS
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, bsn,ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6538109
• MDR Text Key: 74409205
• Report Number: 1219977-2017-00058
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• 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