BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4505753 · Received February 11, 2015

    Report

    Report Number
    2953161-2015-00018
    Event Type
    Injury
    Date Received
    February 11, 2015
    Date of Event
    January 23, 2015
    Report Date
    April 6, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED THE DATE OF EVENT.

    Additional Manufacturer Narrative · 1

    PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO THROMBUS AND DEVICE OCCLUSION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A RIGHT COMMON ILIAC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TRUNK WAS IMPLANTED ON THE LEFT SIDE AND A CONTRALATERAL LEG AND AN ILIAC EXTENDER COMPONENTS WERE IMPLANTED ON THE RIGHT SIDE. THE RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY COVERED BY THE ILIAC EXTENDER. IT WAS REPORTED THAT THE DISTAL END OF THE PXL LANDED AT THE CURVE IN THE EXTERNAL ILIAC ARTERY. NO CALCIFICATION OR THROMBOSIS WAS REPORTED. ON (B)(6) 2015, THE OCCLUSION OF THE RIGHT LIMB WAS OBSERVED. IT WAS REPORTED THAT THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY KINKED AT THE DISTAL END OF THE PXL, AND THE THROMBUS FORMED IN THE PXL DUE TO POOLED BLOOD FLOW. ON (B)(6) 2015, THROMBECTOMY WAS PERFORMED AND A METALLIC STENT WAS IMPLANTED IN THE EXTERNAL ILIAC ARTERY. THE BLOOD FLOW IN THE RIGHT LIMB RESTORED, AND THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT¿S WEIGHT, DOB AND MEDICAL HISTORY WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103159 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12821617

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R