BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 6892667 · Received September 25, 2017

    Report

    Report Number
    2017233-2017-00498
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    July 1, 2017
    Report Date
    October 3, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED PATIENT¿S MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® VIABAHN® ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), DEVICE-RELATED COMPLICATIONS AND ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO THROMBOSIS OR OCCLUSION OF DEVICE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THIS PATIENT PRESENTED WITH AN IATROGENIC PSEUDOANEURYSM OF THE PROPER HEPATIC ARTERY (PHA) AFTER PANCREATICODUODENECTOMY (PD) FOR PANCREATIC CANCER. A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED IN THE PHA. ITS DISTAL END WAS LOCATED PROXIMAL TO THE ORIGIN OF THE MIDDLE HEPATIC ARTERY (MHA), SO THE MHA WAS NOT COVERED. HEMOSTASIS WAS ACHIEVED, AND NO ISSUE WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ANTIPLATELET THERAPY HAD NOT BEEN ADMINISTERED AND MAY HAVE CONTRIBUTED TO THE OCCLUSION. ONE WEEK AFTER THE INITIAL PROCEDURE, COMPUTED TOMOGRAPHY (CT) CONFIRMED THERE WAS BLOOD FLOW THROUGH THE ENDOPROSTHESIS. ON AN UNKNOWN DATE IN (B)(6) 2017, CT SHOWED THAT THE ENDOPROSTHESIS WAS OCCLUDED. BLOOD FLOW TO THE RIGHT SIDE OF THE HEPATIC WAS PRESERVED BY INTRAHEPATIC BLOOD FLOW, SO NO INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671777 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 15565076

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization