BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2160211 · Received June 2, 2011

    Report

    Report Number
    9612164-2011-00516
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSIONS: PT VESSEL MORPHOLOGY. USE OF FORCE TO ADVANCE THE STENT. STENT DEFORMATION AND FAILURE TO DELIVER DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 2.25 MM DIAMETER X 18MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN A PT LOCATED IN THE DIAGONAL ARTERY. THE LESION WAS REPORTED TO EXHIBIT 60% STENOSIS FOLLOWING PRE-DILATION. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE AND FORCE WAS USED WHEN ATTEMPTING TO DELIVER THE STENT ACROSS THE TARGET LESION. WHEN THE DEVICE WAS REMOVED FROM THE PT, THE STENT WAS NOTED TO BE DAMAGED. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001034460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK