BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2034902 · Received March 1, 2011

    Report

    Report Number
    2017233-2011-00093
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THIS PATIENT WAS BEING TREATED FOR EVAR USING GORE EXCLUDER AAA ENDOPROSTHESIS. INTRA-OPERATIVELY, AFTER IMPLANTATION OF THE TRUNK-IPSILATERAL LEG COMPONENT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE CONTRALATERAL LEG COMPONENT INTO THE CONTRALATERAL GATE. THE PHYSICIAN FELT RESISTANCE AND DISCOVERED THE PXC TO BE COMING INTO CONTACT WITH THE CONTRALATERAL GATE OF THE PXT. SO AS NOT TO MOVE THE PXT UP THE AORTA, THE PHYSICIAN RETRACTED THE PXC INTO THE SHEATH AND REMOVED IT. UPON WITHDRAWAL, THE DISTAL END OF THE PXC CAUGHT THE EDGE OF THE SHEATH. YOU COULD SEE APPROXIMATELY 2CM OF THE PXC WITH THE DEPLOYMENT LINE HANGING LOOSE FROM THAT AREA. THE DISTAL END OF THE PXC BROKE FROM THE OLIVE TIP BUT WAS STILL IN ONE PIECE - THIS DEVICE WAS DISCARDED AT THE HOSPITAL. THE PHYSICIAN ADVANCED THE DILATOR INTO THE CONTRALATERAL GATE OF THE PXT AND UTILIZED A NEW PXC FOR CANNULATION. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO INJURY WAS MADE TO THE PATIENT.

    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 WLG425 8124434

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| O