BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2881253 · Received December 20, 2012

    Report

    Report Number
    9612164-2012-01814
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    May 3, 2011
    Report Date
    September 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (MI).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID RCA AND 2 ENDEAVOR SPRINT RX STENTS WERE ALSO IMPLANTED IN THE LAD. THE FOLLOWING DAY THE PATIENT SUFFERED A MI. IT IS UNKNOWN WHETHER THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE EVENT WAS UNRELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005237320

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization ASA AND CLOPIDOGREL