BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 2982043 · Received February 28, 2013

    Report

    Report Number
    9612164-2013-00219
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER THE STENT). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER THE STENT). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE AN ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO TREAT A LESION IN A PATIENT. IT WAS REPORTED THAT THE STENT WOULD NOT DEPLOY. THE DEVICE WAS SUCCESSFULLY WITHDRAWN. POST PROCEDURE PATIENT STATUS WAS GOOD AND NO CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE RX) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY RX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87855 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006082290

    Patients

    Seq Age Sex Outcome Treatment
    1