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

Catalog Number ECH060040

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.The investigation is still ongoing.The results will be included in the final report.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for a left arteriovenous humero-axillary bypass with a gore® acuseal vascular graft.It was stated that the prosthesis was implanted on (b)(6) 2020 in order to create an access for hemodialysis.It was reported that follow-up was marked by a thrombosis requiring a thrombectomy on (b)(6) 2020.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-review.Phr-review: a review of the manufacturing records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: yes.Minimal, scattered plaques of red/brown material were present on the abluminal surface.A foci of red/brown tissue was observable in the lumen when viewed from extremity b.The lumen patency could not be determined with the images provided.Multiple forceps marks were present on the abluminal surface.One perforation (presumptive cannulation) was present.Partially circumferential blue running suture was present near extremity a, closing a clean-edge transection.Both extremities were transected, with extremity b presenting in an ovular shape.Material disruptions observed (i.E., forceps marks, perforation, transections) are consistent with those caused by surgical instrumentation (i.E., forceps, cannulation needle, scalpel/scissors) likely used during a surgical procedure.Request for additional analysis: no.Reason: based on the ei¿s review of the geprovas report and reason for explant (infection), no additional analysis is requested.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10868112
• MDR Text Key: 217117717
• Report Number: 2017233-2020-01464
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR