BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3070009 · Received April 22, 2013

    Report

    Report Number
    9612164-2013-00450
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 8, 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: FAILURE TO DELIVER AND STENT DEFORMATION. LESION MORPHOLOGY. 80-90% STENOSIS AND SEVERE CALCIFICATION. DEFORMATION PROBLEM. CONCLUSIONS: LESION MORPHOLOGY. 80-90% STENOSIS AND SEVERE CALCIFICATION. FAILURE TO DELIVER AND STENT DEFORMATION. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER 1 ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A SEVERELY CALCIFIED LESION IN THE LAD WITH 90% STENOSIS BUT THE DEVICE COULD NOT CROSS. DEVICE WAS REMOVED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 1ST AND 2ND DISTAL SEGMENTS WERE RAISED AND DEFORMED. 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
    171229 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006193513

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR