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

Model Number	25135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8582536
• Report Number: 3011175548-2019-00513
• Device Sequence Number: 2319257
• Product Code: DSY
• UDI-Device Identifier: 00650862251357
• UDI-Public: 00650862251357
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention