BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2092740 · Received May 10, 2011

    Report

    Report Number
    9612164-2011-00387
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    April 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): EVALUATION: RESULTS: (MI).

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 15 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT, WAS DEPLOYED IN THE PROX LAD OF A PT; HOWEVER IT WAS REPORTED THAT THE PT SUFFERED AN MI DURING PROCEDURE. INVESTIGATOR REPORTED THAT THE EVENT WAS UNRELATED TO THE STUDY STENT AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001118592

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization BETA| ASA| LIPID LOWERING DRUG| ACE| NITRATE| CLOPIDOGREL