BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3014206 · Received March 21, 2013

    Report

    Report Number
    9612164-2013-00320
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (DISSECTION). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    THERE WERE TWO RESOLUTE INTEGRITY DRUG ELUTING STENTS IMPLANTED IN THE RCA DURING THE INDEX PROCEDURE; THE SECOND RESOLUTE INTEGRITY STENT WAS IMPLANTED TO TREAT AN EDGE DISSECTION THAT OCCURRED DURING THE IMPLANTATION OF THE FIRST RESOLUTE INTEGRITY STENT. INVESTIGATOR INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117556 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention CLOPIDOGREL AND ASPIRIN.