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

Catalog Number ECH060040J

Device Problem Mechanical Problem (1384)

Patient Problem Occlusion (1984)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On an unknown date, the patient was implanted a gore® acuseal vascular graft in the left arm across elbow for a dialysis shunt.The patient tolerated the procedure.On an unknown date in (b)(6) 2019, it was observed the gore® acuseal vascular graft was occluded.The percutaneous transluminal angioplasty (pta) was performed to resolve the occlusion.At that time, the echo examination reportedly did not identify the delamination.On an unknown date in (b)(6) 2019, re-occlusion of the gore® acuseal vascular graft was observed.The occlusion site was removed and the non-gore graft was implanted as a replacement.The physician reportedly visually confirmed the removed graft and noticed the delamination.The patient tolerated the procedure.It was reported that the delamination site was not cannulated.The physician reportedly stated the bending and extending of the elbow possibly led to the delamination.The physician also suggested that the cause of the re-occlusion was the delamination, the delamination reportedly made the lumen narrow causing the re-occlusion.

Manufacturer Narrative

Engineering evaluation states, based on the evaluation of the event description as the device was not returned, the following observations were made: the identity of the returned device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The provided image is consistent with the event description in that the device is pictured with outer component delamination; however, the location of the delamination relative to cannulation sites and/or patient anatomy could not be confirmed.The device image provided is consistent with the reported event codes; however, the provided device image was insufficient to conduct a root cause evaluation.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9484666
• MDR Text Key: 185085898
• Report Number: 2017233-2019-01240
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040J
• 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): Hospitalization; Required Intervention