BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3499867 · Received December 2, 2013

    Report

    Report Number
    2953161-2013-00184
    Event Type
    Injury
    Date Received
    December 2, 2013
    Date of Event
    November 2, 2013
    Report Date
    November 8, 2013
    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

    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) 2013, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM AT THE AORTIC ARCH USING TWO GORE TAG THORACIC ENDOPROSTHESES AND THREE ILIAC EXTENDER COMPONENTS OF GORE EXCLUDER AAA ENDOPROSTHESIS. THE PHYSICIAN FIRST IMPLANTED (B)(4)DISTALLY AT THE DESCENDING AORTA THEN IMPLANTED (B)(4) PROXIMALLY AT THE AORTIC ARCH. IN ORDER TO PRESERVE THE BLOOD FLOWS INTO THE LEFT SUBCLAVIAN ARTERY, THE PHYSICIAN POKED HOLES ON THE SIDE WALL OF THE (B)(4) USING A "NEEDLE" ADVANCED FROM EACH BRANCH VESSEL AND IMPLANTED THE ILIAC EXTENDER COMPONENTS FROM EACH OF THREE VESSELS TO THE TGT 4015. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAK AND THE PATENCY OF ALL THREE VESSELS. THE PROCEDURE CONCLUDED WITH NO COMPLICATIONS REPORTED. ON (B)(6) 2013, DIGITAL SUBTRACTION ANGIOGRAPHY (DS) IMAGES SHOWED THAT THE ILIAC EXTENDER COMPONENT ((B)(4)), WHICH WAS SUPPOSED TO BE DEPLOYED INSIDE THE (B)(4) FROM THE BRACHIOCEPHALIC ARTERY, WAS ACTUALLY DEPLOYED OUTSIDE THE (B)(4), PRESSED AGAINST THE AORTIC WALL. IN ORDER TO RESTORE THE BLOOD FLOW INTO THE BRACHIOCEPHALIC ARTERY, (B)(4) WAS EXTENDED WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT ((B)(4)) TO CREATE A "CHIMNEY." THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623011 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 11188871

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R