BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4160815 · Received October 10, 2014

    Report

    Report Number
    9612164-2014-01305
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSIONS: FAILURE TO DELIVER STENT AND STENT DEFORMATION, THE LESION HAD 90% STENOSIS. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO USE AN ENDEAVOR RESOLUTE DRUG ELUTING STENT. THE TARGET LESION WAS IN THE DISTAL RCA AND HAD 90% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE COULD NOT PASS THE LESION. ANOTHER NON MEDTRONIC DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT WAS SEVERELY STRETCHED AND DEFORMED. THE DISTAL STENT SEGMENTS WERE STRETCHED OVER THE DISTAL MARKER BAND AND THE DISTAL TIP. CRIMP IMPRESSIONS WERE EVIDENT ON THE BALLOON. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642140 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006834611

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR