BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRING RX CORONARY STENT SYSTEM

    MDR report key: 2210464 · Received August 8, 2011

    Report

    Report Number
    9612164-2011-00894
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 31, 2010
    Report Date
    July 14, 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: (STENT THROMBOSIS).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID LAD AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID CIRCUMFLEX. APPROXIMATELY TWO WEEKS POST IMPLANT AND THE PT WAS REHOSPITALIZED DUE TO CHEST PAIN THE FOLLOWING DAY A FOLLOW-UP ANGIOGRAM WAS PERFORMED. REASON FOR ANGIOGRAM WAS SUSPECTED STENT THROMBOSIS. IT IS UNK WHETHER THE REPORTED EVENT IS RELATED TO THE STUDY STENT. (REF MFR # 9612164-2011-00895).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRING RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000906345

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization LIPID LOWERING DRUGS| DIURETICS| THE PATIENT WAS TAKING ACE INHIBITORS| AND ASA AT TIME OF EVENT.| CLOPIDOGREL