BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 23644734 · Received November 25, 2025

    Report

    Report Number
    2017233-2025-06868
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 17, 2022
    Report Date
    February 13, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    UDI-DI
    00733132605347
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTICE THAT THE FOLLOWING CODES IN THE INITIAL MEDWATCH WERE REPORTED INCORRECTLY: E2337 STENOSIS, E2328 OBSTRUCTION/OCCLUSION AND A0106 DEVICE STENOSIS. THE CODE A0101 PATIENT -DEVICE INCOMPATIBILITY WAS CHOSEN FOR ISCHEMIA (ARTERIAL STEAL SYNDROME). ENGINEERING INVESTIGATION: THE DEVICE WAS NOT RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED IN THIS CASE WAS AN ADVERSE EVENT REPORT FROM A PHYSICIAN ABOUT FOUR SUSPECTED DEVICE DELAMINATION OCCURRENCES ON FOUR SEPARATE GORE® ACUSEAL VASCULAR GRAFT DEVICES USED ON ONE PATIENT, IN ADDITION TO ULTRASOUND AND PHLEBOGRAPHY IMAGES. THIS EVALUATION WILL BE SPECIFIC TO DEVICE WITH SERIAL NUMBER (B)(6). THE IDENTITY OF THE DEVICE WAS PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD WAS EXAMINED AND DID NOT IDENTIFY ANY POTENTIAL ROOT CAUSES ATTRIBUTABLE TO THE MANUFACTURE OF THE DEVICE. THE CASE DESCRIPTION COULD NOT BE CONFIRMED AS NO IMAGES WERE PROVIDED FOR EVALUATION. THE REPORTED FAILURE MODE REFLECTS THE CASE DESCRIPTION BUT COULD NOT BE CONFIRMED. AS SEVERAL DEVICES WERE IMPLANTED IN THE SAME PATIENT, MANUFACTURER REPORT NUMBERS 2017233-2025-06824, 2017233-2025-06869, 2017233-2025-06875 WERE SENT.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3:-OTHER: AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE PERFORMED. PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING AND HEPARIN COATING RECORDS INDICATED THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. FURTHER DETAILS AND CLINICAL IMAGES WERE REQUESTED FROM THE PHYSICIAN, BUT NOTHING WAS PROVIDED YET. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT SURGICAL TREATMENT FOR DIALYSIS ACCESS IN THE ARM WITH A GORE® ACUSEAL VASCULAR GRAFT. IT WAS STATED FROM THE VASCULAR SURGEON THAT ON (B)(6) 2022, BRACHIO-BASILIC ARTERIOVENOUS A 6 MM GORE® ACUSEAL VASCULAR GRAFT WAS IMPLANTED IN THE ARM. ON (B)(6) 2022, THE IMPLANT THROMBOSED. THE PATIENT RECEIVED THROMBOLYSIS WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AT THE BASILIC VEIN AND AT THE VENOUS SITE OF THE VASCULAR GRAFT. THERE WAS ALSO RESIDUAL STENOSIS DETECTED AND AT THE PHLEBOGRAPHY DELAMINATION CAN BE SUSPECTED JUST BEFORE THE VENOUS ANASTOMOSIS AND STENOSIS ON THE VENOUS SIDE WHICH WAS OPENED WITH PTA. ON (B)(6) 2022, THE PROSTHESIS OCCLUDED AND DURING OPEN SURGICAL PROCEDURE IT WAS DETECTED THAT THE BASILIC VEIN WAS THROMBOSED AT THE ANASTOMOTIC SITE. AN OPEN THROMBECTOMY WITH A FOGARTY CATHETER WAS PERFORMED AND A SO CALLED ¿JUMP-GRAFT¿ WAS OPERATED AT THE VENOUS SITE OF THE FORMER GRAFT WITH INTERPOSITIONING OF A NEW 6 MM GORE® ACUSEAL VASCULAR GRAFT ((B)(4) MANUFACTURER REPORT NUMBER 2017233-2025-06824). LATER, THE PATIENT SUFFERED FROM ISCHEMIA OF THE HAND (STEAL) ON THE OPERATED SITE. ON (B)(6) 2022, PROXIMALISATION OF ARTERIAL ANASTOMOSIS (PAI) WAS PERFORMED. A NEW GORE® ACUSEAL VASCULAR GRAFT WAS IMPLANTED AT THE UPPER ARM ON THE SAME SIDE. AT BOTH, FORMER ARTERIAL AND VENOUS ANASTOMOTIC SITES, A SMALL PART OF THE PREVIOUS GRAFT WERE LEFT, BUT OTHERWISE A TOTALLY NEW VASCULAR GRAFT WAS IMPLANTED. AFTER THIS, THE GRAFT WAS USED FOR HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715665 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC. 00733132605347

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention