BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2231148 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01013
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    March 18, 2011
    Report Date
    February 6, 2013
    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 3.5MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE MID CX. NO RE-FLOW WAS OBSERVED DURING PROCEDURE. IT WAS REPORTED THAT THE PT SUFFERED AN MI ONE DAY POST PROCEDURE. IT WAS REPORTED THAT THE PT WAS ASYMPTOMATIC ON DISCHARGE. NO OTHER CLINICAL SEQUELAE WERE REPORTED. INVESTIGATOR REPORTED THAT THE EVENT WAS UNRELATED TO THE STUDY STENT AND PROBABLY 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 0002833292

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR ASA| CLOPIDOGREL