MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problems Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)

Patient Problem Perforation (2001)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

Implant date: the exact implant date in 2018 is unknown; therefore, (b)(6) 2018 is used as the approximate implant date.The explant is unavailable and a lot number was not provided; therefore, an investigation is unable to be performed and a cause of the reported event cannot be determined.The gore® acuseal vascular graft instructions for use note that multiple punctures in the same area may lead to disruption of the graft material.

Event Description

The following was reported to gore: on an unknown date in 2018, the patient received a gore® acuseal vascular graft implant to repair stenosis and occlusion of the arteriovenous fistula using straight design over the elbow of the forearm.The patient tolerated the procedure.On an unknown date in (b)(6) 2019 (before (b)(6)), it was observed in an examination that the graft appeared to be delaminated at the site of cannulation.On (b)(6) 2019, the gore® acuseal vascular graft was removed, except for the site of anastomosis.Another graft (non-gore device) was implanted as a replacement of the gore® acuseal vascular graft to repair the hemodialysis shunt.The physician¿s comments: the site where the delamination was observed was cannulated many times, and it was near the elbow.It is possible that the tear appeared due to the cannulation, and the delamination may have occurred due to the blood flow into the layer from the tear.

Manufacturer Narrative

Device application: the gore® acuseal vascular graft was used specifically for a cephalic vein-basilic vein bypass.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8666556
• MDR Text Key: 146925197
• Report Number: 2017233-2019-00384
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR