BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY SPRINT RX

    MDR report key: 2190948 · Received July 28, 2011

    Report

    Report Number
    9612164-2011-00855
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (MYOCARDIAL INFARCTION/OCCLUSION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID LAD. THE SAME DAY AS THE INDEX PROCEDURE, THE PT SUFFERED A MI. THE MI WAS DUE TO A LATERAL BRANCH OCCLUSION. IT WAS REPORTED THAT THE MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY SPRINT RX NIQ MEDTRONIC IRELAND NA 0005232203

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization NITRATE| BETA-BLOCKERS| CLOPIDOGREL| ASA| ACE| LIPID LOWERING DRUGS