BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 2832952 · Received November 15, 2012

    Report

    Report Number
    9612164-2012-01655
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: STENT DEFORMATION AND FAILURE TO DELIVER THE STENT ARE LISTED IN THE PRODUCT IFU AS INHERENT RISKS OF STENTING PROCEDURES. THE ROOT CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO PATIENT LESION MORPHOLOGY. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN PATIENT. IT WAS REPORTED THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE STENT BECAME DAMAGED. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006317954

    Patients

    Seq Age Sex Outcome Treatment
    1