BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 14861490 · Received June 29, 2022

    Report

    Report Number
    2017233-2022-03070
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    September 1, 2021
    Report Date
    June 29, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AND EVENT INFORMATION WERE REQUESTED, BUT AUTHOR DECLINED TO PROVIDE ANY DETAILS. AS A RESULT, FURTHER INVESTIGATION WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE STATE: THE GORE® ACUSEAL VASCULAR GRAFT CAN BE CANNULATED EARLY (WITHIN 24 HOURS AFTER IMPLANTATION). PATIENTS SHOULD BE CAREFULLY MONITORED WHEN USING GORE® ACUSEAL VASCULAR GRAFTS FOR VASCULAR ACCESS. PUNCTURE SITES MUST BE ADEQUATELY SEPARATED WHEN REPEATED NEEDLE PUNCTURES OF THE GRAFT ARE NECESSARY. MULTIPLE PUNCTURES IN THE SAME AREA MAY LEAD TO DISRUPTION OF THE GRAFT MATERIAL OR FORMATION OF A PERIGRAFT HEMATOMA OR PSEUDOANEURYSM. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 0

    THE FOLLOWING PUNISHMENT WAS REVIEWED BY GORE: TITLE: DELAMINATION OF ACUSEAL EARLY CANNULATION ARTERIOVENOUS GRAFT MONTHS AFTER IMPLANTATION SOURCE: J VASC ACCESS. 2021 SEP;22(5):840-844, CORRESPONDING AUTHOR: KOTARO SUEMITSU. ABSTRACT: ARTERIOVENOUS FISTULA IS RECOMMENDED, BUT ARTERIOVENOUS GRAFT IS ACCEPTABLE WHEN A FISTULA IS NOT POSSIBLE. ACUSEAL IS AN EARLY CANNULATION GRAFT WITH A TRILAYER STRUCTURE. ALTHOUGH PRIMARY PATENCY RATES OF ACUSEAL APPEAR TO BE SIMILAR TO THOSE OF OTHER STANDARD GRAFTS, FEW STUDIES HAVE INVESTIGATED LONG-TERM RESULTS AND COMPLICATIONS. IN OUR SERIES, DELAMINATION OF THE WALL STRUCTURE OCCURRED IN 5.1% (6/115) BY 21 MONTHS AFTER ACUSEAL IMPLANTATION. THE CAUSES COULD BE DIVIDED INTO CANNULATION-RELATED AND CANNULATION-UNRELATED. HERE, WE DESCRIBE THE SIX CASES IN WHICH DELAMINATION OF THE WALL STRUCTURE OCCURRED IN THE MEDIUM TERM AFTER ACUSEAL IMPLANTATION. CASE PATIENT 3: A 66-YEAR-OLD MALE HAD A 6.0 MM ACUSEAL IMPLANTED IN HIS LEFT FOREARM (LOOP GRAFT; INFLOW, PROXIMAL RADIAL ARTERY; OUTFLOW, MEDIAN CUBITAL VEIN). HE STARTED HEMODIALYSIS 2 DAYS LATER. OCCLUSION WAS NOTED 7 MONTHS AFTER AVG IMPLANTATION AND VAIVT WAS REQUIRED. AT THIS TIME, NO DELAMINATION OF THE AVG WAS OBSERVED. THREE MONTHS AFTER VAIVT, HOWEVER, DELAMINATION OF THE POSTERIOR WALL OF THE VENOUS PUNCTURE SITE WAS DETECTED BY ULTRASOUND. THERE WAS NO VAIVT. HE DIED 3 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091361 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male