BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230850 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01021
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    A
    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 REC'D A 2.75MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE MID LAD. STENT IMPLANT WAS SUCCESSFUL; HOWEVER IT WAS REPORTED THAT THE PT SUFFERED AN MI ONE DAY POST PROCEDURE. IT WAS REPORTED THAT THE PT WAS ASYMPTOMATIC ON DISCHARGE. INVESTIGATOR REPORTED THAT THE EVENT WAS UNRELATED TO THE STUDY STENT AND PROBABLY RELATED TO THE PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0003134629

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR BETA| CLOPIDOGREL| DIURETIC| NITRATE| LIPID LOWERING DRUG| ASA| ACE