BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143365 · Received May 24, 2013

    Report

    Report Number
    2953161-2013-00078
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 28, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OD THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE CAUSE OF THE ANEURYSM GROWTH IS UNK. DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PCT281416/033141003, PCC181000/02835404 AND PXC141400/9313987. REFER TO MEDWATCH # 2017233-2011-00607 FOR THE INFORMATION ON THE (B)(6) 2011 PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2004, THE PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER BIFURCATED ENDOPROSTHESES. ON (B)(6) 2011, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO TREAT A DISTAL TYPE I ENDOLEAK. ON (B)(6) 2013, FOLLOW-UP IMAGING SHOWED THAT THE ANEURYSM HAD GROWN 3CM OVER THE PAST 18 MONTHS, WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2013, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY THE PREVIOUSLY IMPLANTED DEVICES WERE RELINED WITH THREE ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED A CAUSE OF THE ANEURYSM ENLARGEMENT WAS NOT IDENTIFIED. FINAL IMAGING SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2013, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY IDENTIFIED A PERSISTENT PROXIMAL ANTERIOR ENDOLEAK. THE SOURCE OF THE ENDOLEAK COULD NOT BE IDENTIFIED. ON (B)(6) 2013, REPEAT ANGIOGRAPHY REPORTEDLY SHOWED A TYPE II ENDOLEAK, MOST LIKELY FROM A LUMBAR ARTERY. NO FURTHER ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232694 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 033141003

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R HYDROCHLOROTHIAZIDE| ASPIRIN| CYANOCOBALAMIN| CHOLECALCIFEROL| PYRIDOXINE| FOLIC ACID| METOPROLOL TARTRATE| SIMVASTATIN| ACETAMINOPHEN