BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2092748 · Received May 10, 2011

    Report

    Report Number
    9612164-2011-00393
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 12, 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: (MI).

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) AND A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RX DRUG ELUTING CORONARY STENTS, WERE DEPLOYED IN THE MID LAD AND MID CX OF A PT WITH NO ISSUE REPORTED; HOWEVER IT WAS REPORTED THAT THE PT SUFFERED AN MI ONE DAY POST PROCEDURE. INVESTIGATOR REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT AND PROBABLY RELATED TO THE PROCEDURE. (REF MFR 9612164-2011-00394).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization CLOPIDOGREL| BETA| LIPID LOWERING DRUG| ASA