BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2963050 · Received February 15, 2013

    Report

    Report Number
    9612164-2013-00183
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DISSECTION. CONCLUSIONS: DISSECTION. (B)(4).

    Description of Event or Problem · 1

    ONE RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE CX. DURING THE PROCEDURE A DISSECTION OCCURRED. A SECOND RESOLUTE INTEGRITY DRUG ELUTING STENT WAS DEPLOYED AS BAILOUT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67082 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006432391

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention CLOPIDOGREL AND ASPIRIN.