BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3914812 · Received July 4, 2014

    Report

    Report Number
    9612164-2014-00704
    Event Type
    Injury
    Date Received
    July 4, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. TWO RESOLUTE INTEGRITY DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE LCX AND ONE IN THE OM. APPROXIMATELY 9 MONTHS LATER, THE PATIENT SUFFERED A SECOND MI, WHICH WAS TREATED WITH POBA OF THE OM AND THE PLACEMENT OF ONE NON-MEDTRONIC STENT IN THE CX. THE OUTCOME WAS REPORTED AS RESOLVED. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392711 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006594229

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention