BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1873461 · Received October 14, 2010

    Report

    Report Number
    2953161-2010-00185
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 13, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. EVAL SUMMARY: THE RETURNED PRODUCT SHOWED THAT THE POLYIMIDE GUIDEWIRE LUMEN DETACHED AT THE PROXIMAL JUNCTION, AND THE DEPLOYMENT KNOB REMAINED SCREWED DOWN. THIS INDICATES THE DEPLOYMENT WAS INITIATED WITHOUT PULLING THE DEPLOYMENT KNOB. THE EVENT DESCRIPTION STATES, THE DEVICE WAS PUSHED HALF WAY OUT OF THE SHEATH. THE WARNING SECTION OF IFU CLEARLY STATES, "DO NOT ADVANCE THE DEVICE OUTSIDE OF THE SHEATH." THE SHEATH WILL PROTECT THE DEVICE FROM CATHETER BREAKAGE OR PREMATURE DEPLOYMENT WHILE TRACKING IT INTO POSITION.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING ADVANCEMENT OF A CONTRALATERAL LEG COMPONENT, THE SHEATH WOULD NOT ADVANCE ALL THE WAY. THE PHYSICIAN ATTEMPTED TO PUSH THE DEVICE UP WITHOUT THE SHEATH. THE DEVICE WAS PUSHED HALF WAY OUT OF THE SHEATH. THE DEVICE WOULD NOT ADVANCE SO THE PHYSICIAN BEGAN TO WITHDRAWAL THE DEVICE AND SHEATH. IT WAS NOTICED THE POLYIMIDE TUBING HAD SEPARATED FROM THE CATHETER. THE GRAFT PARTIALLY DEPLOYED IN THE SHEATH. BOTH THE DEVICE AND CATHETER WERE REMOVED FROM THE PT. ANOTHER CONTRALATERAL LEG COMPONENT AND SHEATH WERE USED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    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 WLG325 7493239

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR ASPIRIN| PROCARDIA