BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 4182508 · Received October 17, 2014

    Report

    Report Number
    2953200-2014-02118
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE CASE WAS AN EMERGENT CASE. THE PACKAGING WASN'T DAMAGED. A SECOND DEVICE WAS USED SUCCESSFULLY. THE PATIENT IS FINE. EVALUATION SUMMARY: UPON INSPECTION OF THE DEVICE, THERE WAS A COMPLETE BREAK IN THE SCREW GEAR JUST BELOW THE EXTERNAL SLIDER, WHICH ALIGNED WITH CORRESPONDING DAMAGE TO THE PACKAGING (THERE WAS AN ANNOTATION ON THE TRAY POINTING TO THE DAMAGED SCREWGEAR). THERE WAS A 3 MM GAP BETWEEN THE GRAFT COVER AND TAPERED TIP, AS WELL AS A 3 MM GAP BETWEEN THE STENT STOP CUP AND STENT GRAFT. THE ENTIRE DELIVERY SYSTEM WAS COVERED IN AN UNKNOWN WHITE FILM. WHEN THE DEVICE WAS REMOVED FROM THE TRAY, THE GRAFT COVER HAD A SLIGHT BEND; OTHERWISE, THE GRAFT COVER WAS UNREMARKABLE. THE WHEEL WAS INTACT AND DID NOT APPEAR DAMAGED. THE PIGGYBACK LABEL WAS REMOVED FROM THE DEVICE. THE REPORTED EVENT WAS NOT CONFIRMED; THERE WAS DAMAGE TO THE SCREWGEAR, BUT NONE TO THE WHEEL OR GRAFT COVER. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, SHIPPING AND HANDLING MOST LIKELY CONTRIBUTED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS SELECTED FOR USE. IT WAS REPORTED THAT WHEN THE PHYSICIAN TOOK THE PRODUCT OUT OF THE PACKAGING, HE NOTICED THAT THE CATHETER WAS TWISTED AND THAT THE BACK END WHEEL WAS BROKEN. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660549 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05887399

    Patients

    Seq Age Sex Outcome Treatment
    1