BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1880973 · Received October 5, 2010

    Report

    Report Number
    2953200-2010-01888
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. THE STENT SEGMENTS WERE SLIGHTLY RAISED AND TWISTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT(B)(4). (B)(4). RESULTS: 70% STENOSIS, STENT DEFORMATION AND FAILURE TO DELIVER THE STENT. CONCLUSIONS: 70% STENOSIS.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.0 MM DIAMETER X 30 MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) CORONARY STENT INTO THE RCA VESSEL WHICH EXHIBITED 70% STENOSIS. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION DESPITE MULTIPLE PRE-DILATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0002317871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK