BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2181154 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00825
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    January 18, 2011
    Report Date
    October 20, 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). EVALUATION: RESULTS: (MYOCARDIAL INFARCTION).

    Description of Event or Problem · 1

    APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE THE PATIENT WAS RE-HOSPITALIZED. RE-PTCA (BALLOONING) OF TARGET LESION WAS PERFORMED DUE TO RESTENOSIS. THE PTCA WAS SUCCESSFUL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE.

    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 LAD AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID RCA. THE SAME DAY AS THE INDEX PROCEDURE, THE PATIENT SUFFERED AN MI. IT WAS REPORTED THAT THE MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE DEVICE. (REF MFR # 9612164-2011-00824).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND NA 0001028088

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R ASA| CLOPIDOGREL| BETA-BLOCKERS| LIPID LOWERING DRUGS| ACE