BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2771921 · Received September 28, 2012

    Report

    Report Number
    2017233-2012-00658
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. AFTER DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG COMPONENT, THE PHYSICIAN WAS UNABLE TO CANNULATE THE CONTRALATERAL GATE, THEREFORE THE PHYSICIAN DECIDED TO UTILIZE A CROSS-OVER TECHNIQUE IN ORDER TO GAIN ACCESS TO THE CONTRALATERAL GATE. A GUIDEWIRE WAS PLACED FROM THE RIGHT SIDE TO THE LEFT SIDE USING A GOOSE NECK CATHETER, HOWEVER WHEN PULLING DOWN ON THE GUIDEWIRE FROM THE CONTRALATERAL FEMORAL ARTERY, THE TRUNK-IPSILATERAL LEFT COMPONENT WAS PULLED DISTALLY INTO THE ANEURYSM SAC. THE DISTANCE FROM THE PROXIMAL END OF THE DEVICE TO THE LOWEST RENAL ARTERY WAS 40MM. THEREFORE THE PHYSICIAN DEPLOYED THREE AORTIC EXTENDER COMPONENTS IN AN ATTEMPT TO OBTAIN PROXIMAL SEAL. HOWEVER, AT THE END OF THE PROCEDURE A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN DECIDED NOT TO TREAT THE ENDOLEAK. THE PT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10420742

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention