BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2192818 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00769
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PROCEDURAL IMAGES WERE NOT PROVIDED AND BASED ON THE LIMITED INFO RECEIVED THE REPORTED IS CANNOT BE CONFIRMED. RESULTS: NO ROOT CAUSE OF EVENT CAN BE DETERMINED BASED ON LIMITED INFO AVAILABLE. INCOMPLETE STENT APPOSITION. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ONE LESION WAS TREATED IN THE INDEX PROCEDURE. ONE RESOLUTE INTEGRITY STENT WAS DEPLOYED IN THE PROX LCX TO TREAT IN STENT RESTENOSIS OF A PREVIOUSLY DEPLOYED BARE METAL STENT. THE STENT WAS IMPLANTED BUT IT WAS NOTED THAT THE STENT FAILED TO EXPAND TO ITS DESIRED DIAMETER. PT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005622410

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR