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

Model Number 25137

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

Patient Problem Occlusion (1984)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

The patient was implanted the flixene (short-tapered) developed vascular occlusion and has been receiving percutaneous transluminal angioplasty repeatedly.The first vascular occlusion occurred at the anastomosis area on the arterial side, and then, also occurred at the anastomosis area on the venous side.This is the first avg for the patient.

Manufacturer Narrative

Based on the review of the device history records and product complaint details atrium can find no fault with the device in question.It is possible that the graft was placed to high within the elbow causing the blood flow to stop when the elbow was bent.Clinical evaluation - an arterio-venous (av) graft is a looped, synthetic tube that connects an artery to a vein.An av graft is a patient¿s lifeline.It is their best option for hemodialysis.Dialysis patients are already in a compromised state of health.It is imperative that the integrity of the graft not be compromised.Grafts are implanted surgically via an open incision and/or sub-cutaneous tunneling in certain applications.Surgeons undertaking such procedures are specialists and have the skills necessary to be working in an operative suite and are supported by trained staff.Even in that advent situations may arise that may be reasonably expected and appropriate intervention may need to be performed, such as bypassing a damaged graft.The risk to the patient becomes those risks associated with a prolonged procedure, pain or the potential of injury to surrounding tissue.The patient population that needs a vascular graft usually has pre-existing risk factors for thrombosis including coagulopathies, smoking, hypertension and dyslipidemia.Long term patency of the graft post intervention to correct an occlusion may be due to those very risks.Flixene vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.Patency of a graft ensures the continuation of blood flow to an extremity or organ.If a graft loses patency it can be the cause of ischemia, thrombosis, tissue death and loss.Patency may be affected by any number of occurrences including progression of pre-existing vascular disease, thrombosis formation.The instructions for use (ifu) states complications that may occur in connection with the use of any vascular graft include, but are not limited to, thrombosis, formation of pseudo-aneurysm due to excessive, localized, multiple and/or large needle punctures, perigraft hematoma formation, perigraft seroma formation or ultrafiltration, excessive needle hole bleeding or weeping, infection, swelling of tissue, suture hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material, suture line or host vessel which may result in extreme blood loss, loss of limb function, loss of limb or possible death.

Event Description

N/a.

• Brand Name: FLIXENE GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8192389
• MDR Text Key: 131300593
• Report Number: 3011175548-2018-01521
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862251371
• UDI-Public: 00650862251371
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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: 04/03/2021
• Device Model Number: 25137
• Device Catalogue Number: 25137
• Device Lot Number: 430200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/30/2018
• Supplement Dates FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2018
• 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