BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2080532 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00283
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 28, 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: MI.

    Description of Event or Problem · 1

    PT RECEIVED A 2.5MM DIAMETER X 24MM LENGTH AND A 2.5MM DIAMETER X 20MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX LAD. FIRST DIAGONAL BRANCH WAS ALSO TREATED (BALLOON ONLY) DURING INDEX PROCEDURE. STENT IMPLANT WAS SUCCESSFUL; HOWEVER, IT WAS REPORTED THAT 1 DAY POST STENT IMPLANT, THE PT SUFFERED AN MI. INVESTIGATOR REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT AND THE PROCEDURE. (REF MFR # 9612164-2011-00282).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001134680

    Patients

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