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

Catalog Number ECH060040J

Device Problem Peeled/Delaminated (1454)

Patient Problem Failure of Implant (1924)

Event Date 06/23/2019

Event Type  malfunction  

Event Description

The following was reported to gore: on an unknown date in 2017, a gore® acuseal vascular graft was implanted in this patient's arm for a dialysis shunt.The patient tolerated the procedure.On an unknown date, a graft pseudoaneurysm was observed on the gore® acuseal vascular graft.On (b)(6) 2019, an additional procedure was performed to remove the graft pseudoaneurysm and reconstruct the shunt.The pseudoaneurysmal portion with some proximal and distal margin of the graft was explanted.At that time, the physician observed a delamination between outer layer and silicone layer on the cut section of the graft.The range of the delamination was reportedly around 1cm.It was also reported that the position of the cut section corresponded with a cannulation site.A gore® propaten® vascular graft was anastomosed to the remaining portion of the gore® acuseal vascular graft to reconstruct the shunt.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 8889838
• MDR Text Key: 154304931
• Report Number: 2017233-2019-00638
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2019

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
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other