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

Catalog Number ECH060040J

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Occlusion (1984); No Code Available (3191)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

(delamination and removal of a portion of the device).

Event Description

The following was reported to gore: on (b)(6) 2017, this patient was implanted with a gore® acuseal vascular graft as an av shunt in the right forearm middle radial artery ¿ upper arm middle basilic vein for hemodialysis to treat chronic renal failure.On (b)(6) 2019, the patient presented with reported shunt occlusion.The ultrasound examination revealed delamination at the elbow.The area of delamination was reportedly a non-puncture site.On (b)(6) 2019, a new dialysis shunt in the right forearm middle radial artery ¿ upper arm middle deep vein was constructed using gore® propaten® vascular graft.Reportedly, it appeared that the delamination portion had been removed.The physician reportedly stated he believes since the delamination occurred near elbow, a non-puncture site, the load on acuseal due to the movement of the elbow might be the cause of delamination.

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 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 event description could not be confirmed, as no identity or images of the device were provided for 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: 9497366
• MDR Text Key: 183087565
• Report Number: 2017233-2019-01258
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 38