BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3802957 · Received May 9, 2014

    Report

    Report Number
    2953200-2014-00962
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 17, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW INSTRUCTIONS (USED DAMAGED DEVICE). (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LARGER THAN 5CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. DURING THE INDEX PROCEDURE THE PHYSICIAN NOTICED A KINK ON THE PROXIMAL GRAFT COVER TUBING, APPROXIMATELY 15CM FROM THE HANDLE. THERE WAS NO VISIBLE DAMAGE ON THE PRODUCT PACKAGING. THE KINK WAS IDENTIFIED JUST BEFORE INSERTING THE DEVICE INTO THE PATIENT. THE PHYSICIAN TRIED TO INSERT THE GUIDE WIRE UNSUCCESSFULLY. THE PHYSICIAN MANIPULATED THE DEVICE/STRAIGHTENED IT AND THE GUIDE WIRE WAS INSERTED SUCCESSFULLY. THE DEVICE WAS USED SUCCESSFULLY WITH NO INJURIES TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AND ITS EVALUATION IS COMPLETE. THE EVENT WAS CONFIRMED; THERE WAS A KINK IN THE GRAFT COVER. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED SINCE THE DEVICE WAS USED DURING THE PROCEDURE; HOWEVER, SHIPPING AND HANDLING MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280804 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04062000

    Patients

    Seq Age Sex Outcome Treatment
    1