MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE VASCULAR GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician could not determine patency at the follow up visit.The function of the graft was still fine but the flow could not be seen on echo.

Manufacturer Narrative

It was reported that the "physician could not determine patency at the follow up visit.The function of the graft was still fine but the flow could not be seen on echo".A review of the complaint details indicate that the graft was fine but the physician using an echocardiogram could not determine the patency of the graft.Atrium medical does not suggest what type of methodology is to be used to assess the patency of the graft.The flixene av access graft cannulation education pocket guide, post cannulation care does state the following: "before the patient leaves the unit, assess and document the quality of the bruit and thrill".A bruit (a pulse that you can hear), a thrill (a pulse that can be felt).No product was returned and no images or the lot number of the device were provided in order to aid in the investigation, therefore the complaint cannot be confirmed.There have been no other inquiries or complaints regarding the flixene grafts and the use of an echocardiogram to determine blood flow.Based on the details provided the root cause is considered operational context as the device in question was reported by the physician as being fine and the investigation cannot conclude that the design, manufacture or labeling of the flixene graft was the cause for the reported complaint issue.

• Brand Name: FLIXENE VASCULAR GRAFTS
• 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: 10170117
• MDR Text Key: 195716658
• Report Number: 3011175548-2020-00830
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention