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

Model Number 25137

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

Patient Problems Erythema (1840); Swelling (2091)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated during a shunt procedure the patient had a flixene graft placed in the left forearm.Post-surgery the patient exhibited prolonged skin redness and swelling.

Manufacturer Narrative

The device was not returned for evaluation.It is unknown why the patient experienced the redness and swelling a month after implantation.There is no evidence to conclude that the graft was the cause of the patient¿s symptoms.All grafts are supplied sterile using a 100% ethylene oxide eto sterilization cycle.Based on the review of the device history records and product complaint details atrium medical corporation cannot conclude the redness and swelling experience were directly related to the flixene graft.Clinical evaluation: an av graft is a looped, plastic tube that connects an artery to a vein.It is commonly used if the patient¿s veins are too small for an av fistula or if the patient¿s veins are blocked.Grafts can usually be used for dialysis within two to six weeks.Flixene vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.Edema is the swelling of the body's tissues due to excess interstitial fluid retention.Edema can occur locally, often affecting the extremities (peripheral edema), or generally, affecting the entire body (anasarca).Erythema is a superficial reddening of the skin, usually in patches, as a result of injury, infection or irritation causing dilatation of the blood capillaries.Dermatitis occurs when the skin comes into direct contact with a foreign substance that causes an adverse reaction, potentially leading to a rash.The resulting rash may be itchy, red, or inflamed.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, 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 SLIDER 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: 8511965
• MDR Text Key: 141893333
• Report Number: 3011175548-2019-00391
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00065086225137
• UDI-Public: 0065086225137
• 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
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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: 10/24/2021
• Device Model Number: 25137
• Device Catalogue Number: 25137
• Device Lot Number: 436743
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• 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