BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3200841 · Received July 2, 2013

    Report

    Report Number
    9612164-2013-00682
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 24, 2013
    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: INHERENT RISK OF PROCEDURE ¿ (FAILURE TO DELIVER AND STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ CTO LESION. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DEPLOY ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO THE RCA (CTO LESION) BUT THE DEVICE COULD NOT CROSS. LESION HAD BEEN PRE-DILATED. NO PATIENT COMPLICATION WAS REPORTED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 10TH AND 11TH PROXIMAL SEGMENTS WERE RAISED AND DEFORMED. A NUMBER OF OTHER SEGMENTS WERE SLIGHTLY RAISED AND MISALIGNED. THE DISTAL TIP WAS DAMAGED. 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
    303341 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006585080

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR