BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 2843726 · Received November 23, 2012

    Report

    Report Number
    9612164-2012-01695
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - LIMITED INFORMATION, NO DEVICE OR PROCEDURAL IMAGES RETURNED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING ATTEMPTED DELIVERY OF A RESOLUTE INTEGRITY DRUG ELUTING TO A TARGET LESION, THE STENT BECAME DISLODGED FORM THE BALLOON AND REMAINS IN THE PATIENT'S LEG. IT HAS BEEN CONFIRMED THAT PHYSICIAN WAS NOT CONCERNED ABOUT THE STENT THAT HAD MIGRATED TO THE LOWER LEG. CONFIRMATION HAS BEEN RECEIVED THAT THE PATIENT IS WELL WITH NO CLINICAL SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1