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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Investigation: we are unable to fully investigate this report as no product number, lot number or sample was provided.There is no indication that this event is due to a device failure.The use of the graft was for creation of vascular access for dialysis purposes.It is not known what relationship of the graft is to the reported incident.The article indicates that adverse events occurred during the study period and do not indicate how they were related to the grafts used in the procedures.The details provided do not elaborate on the claim further.A review of the mechanical properties and dimensions of the graft lot could not be performed as the product numbers and lot numbers were not provided.Conclusions of the article indicate that the flixene graft is a viable alternative for conventional and complex access creation that allows early cannulation in the majority of cases.

Event Description

Received an article titled: early cannulation graft flixene for conventional and complex hemodialysis access creation.Journal of vascular access, 18(2), pp.109-113.The article discussed the initial experience with this device for conventional and complex hemodialysis access creation.Per the article, procedural complications included adverse events associated with the procedure and follow up.

• Brand Name: FLIXENE VASCULAR GRAFT
• 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, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6534936
• MDR Text Key: 74116079
• Report Number: 1219977-2017-00053
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K051332
• 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
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• 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
• Patient Outcome(s): Required Intervention