BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2945499 · Received February 6, 2013

    Report

    Report Number
    9612164-2013-00127
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (CEREBROVASCULAR ACCIDENT).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS SUCCESSFULLY DEPLOYED AT RCA. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT A NON-TARGET VESSEL REVASCULARIZATION AND HAD TWO RESOLUTE INTEGRITY DRUG-ELUTING STENTS IMPLANTED IN THE LAD. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH SLURRED SPEECH WHICH WAS ASSESSED AS POSSIBLY A STROKE. PATIENT IS BEING TREATED WITH PHYSICAL THERAPY. INVESTIGATOR INDICATED THAT THE EVENT HAD NO RELATIONSHIP TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51183 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization ASPIRIN AND CLOPIDOGREL