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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced redness and swelling that occurred from the hand after placement of the graft.

Manufacturer Narrative

The complaint is in regards to a patient that had redness and swelling after placement of the graft.As with any surgical event there are adverse reactions that could occur.There is even a possibility that the patient was allergic to the eptfe that is used to construct the graft but would be considered extremely rare.The details provided do not indicate or provide any additional information as to the status of the patient or if the redness and swelling resolved on its own or if antibiotics were required.There were also no images of the redness or swelling, therefore the complaint cannot be confirmed.The adverse reactions provided within the instructions for use (ifu) include infection and swelling of tissue.The ifu also states the product is sterile and it provides the following aseptic presentation steps to avoid any contamination of the graft: upon confirming that the correct device has been selected, it is transferred into the sterile field using standard hospital technique.The non-sterile operator should peel open the outer tray exposing the sterile inner tray so the technician within the sterile field may withdraw it from the outer package.The technician managing sterile product should peel the inner tray lid, and remove the graft once the physician is ready to implant it.Note: some grafts will be covered by a blue transfer sleeve.It is recommended that the blue transfer sleeve remain on the graft until the graft is pulled into the subcutaneous plane for implantation.The purpose of the blue transfer sleeve is to minimize graft/sheath contact with foreign material prior to implantation.It is highly recommended that graft contact with other materials be limited in an effort to minimize any potential transfer of foreign materials or bacteria into the operative site.Based on the review of the product complaint details atrium medical corporation cannot conclude that the manufacture or design of the product is at fault.

• Brand Name: FLIXENE VASCULAR GRAFT
• 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: 10170125
• MDR Text Key: 195717908
• Report Number: 3011175548-2020-00829
• 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention