MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE ACUSEAL; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problems Obstruction of Flow (2423); Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 02/16/2023

Event Type  malfunction  

Event Description

Patient had gore accuseal graft placed for hemodialysis (b)(6) 2022.After about 3 months of use, it occluded.Attempts at percutaneous thrombectomy unsuccessful, unable to pass guidewire beyond venous anastomosis.Subsequently taken to or where graft found to have dissected between silicone layer and outer layer.This require replacement of the graft.Patient doing well now.

• Brand Name: GORE ACUSEAL
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 16487365
• MDR Text Key: 310808035
• Report Number: MW5115434
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American