MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE GWT, W/DBL GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 25135

Device Problem No Flow (2991)

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

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a flixene graft was implanted for a patient going on dialysis.The doctor could not hear or feel flow.It was cannulated in the operating room (or) and got blood return.The dialysis unit could not hear or feel flow.An ultrasound was done that showed complete occlusion of the graft.The patient had to go back to the or for explant of the graft.

Manufacturer Narrative

Analysis: the details indicate that a flixene graft was implanted for a patient going on dialysis.The doctor could not hear or feel flow.It was cannulated in the operating room (or) and got blood return.The dialysis unit could not hear or feel flow.An ultrasound was done that showed complete occlusion of the graft.The patient had to go back to the or for explant of the graft.As we have not been provided any further information regarding this case after multiple attempts, an investigation into the reasons why the graft became completely occluded is difficult.There is a possibility that the patient may have had some coagulopathies.There is no mention in the case details if flow had been confirmed directly after implantation of the graft.Without more detail a root cause cannot be determined.Atrium medical corporation has made multiple attempts to obtain more information but a response was never received from the institution.A thorough review of the device history records for this graft lot was conducted.The device lot in question met all quality and performance testing requirements and no non-conformances were noted during the build of the product related to the complaint.Conclusion: based on the review of the device history records and product complaint details atrium medical corporation cannot conclude the occlusion was directly related to the flixene graft.

• Brand Name: FLIXENE GWT, W/DBL GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8582536
• MDR Text Key: 144148112
• Report Number: 3011175548-2019-00513
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862251357
• UDI-Public: 00650862251357
• Combination Product (y/n): N
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2022
• Device Model Number: 25135
• Device Catalogue Number: 25135
• Device Lot Number: 442694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention