GORE® ACUSEAL Vascular Graft

Description of Event or Problem

The following information was reported to Gore:On an unknown date, a patient with end-stage renal disease underwent placement of a GORE® ACUSEAL Vascular Graft (ACUSEAL) as an arteriovenous graft in the left upper arm.On (b)(6)2026, possible delamination of the ACUSEAL was observed on ultrasound examination. A partial replacement was promptly performed using a GORE® PROPATEN® Vascular Graft. The patient tolerated the procedure. The physician decided to monitor it.

Additional Manufacturer Narrative

Heparin Surface incorporates CARMEDA Heparin manufactured from heparin sodium API, which is covalently bound to the device surface and is essentially non-eluting.A1: No patient specific details have been provided. Therefore, the patient initials reflect the W. L. Gore internal case number. H6: A review of the manufacturing records for the device could not be performed as a valid lot number was not provided. W. L. Gore & Associates, Inc. (Gore) is submitting this report to comply with 21 C.F.R. part 803, the Medical Device Reporting regulation. This report is based upon information obtained by Gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the FDA. Blank fields present on this report include required fields and fields determined to be not applicable. Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable. This report does not constitute an admission or a conclusion by FDA, Gore, or its associates that the device, Gore or its associates caused or contributed to the event described in the report. In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint. These words are included in the report and are fixed items for selection created by the FDA, to categorize the type of event solely for the purpose of reporting pursuant to Part 803. This statement should be included with any information or report disclosed to the Public under the Freedom of Information Act.