BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 10231441 · Received July 6, 2020

    Report

    Report Number
    2017233-2020-00463
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 9, 2020
    Report Date
    September 16, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 AND H4 WERE UPDATED AND EVALUATION CODES AS WELL.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #21285461. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 1

    THE ENGINEERING EVALUATION IS STILL ONGOING. THE RESULTS WILL BE INCLUDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN INTERNAL ILIAC ANEURYSM IN THE LEFT HYPOGASTRIC ARTERY WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX-DEVICE). IT WAS STATED THAT AFTER IMPLANTATION OF THE VBX-DEVICE IT WAS TRIED TO RETRACT THE BALLOON CATHETER BUT IT GOT STUCK ON THE WIRE. AS THE SURGEON TRIED TO PULL MORE, THE END OF THE SHAFT DISCONNECTED FROM THE REST OF THE CATHETER. FOR THAT REASON THE WIRE FROM THE TARGET VESSEL HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701508 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W.L. GORE & ASSOCIATES 21285461

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other