BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1901594 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02230
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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

    ADDITIONAL INFORMATION RECEIVED: IT IS UNKNOWN WHETHER THE REPORTED MI WAS RELATED TO THE TARGET VESSEL.

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 15MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN THE MID CX OF A PT (MFR REP # 2953200-2010-02229). DURING PROCEDURE THE PT ALSO REC'D A 3.0 X 24 MM ENDEAVOR SPRINT RX TO TARGET LESION (MDR 2953200-2010-02230) WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT THE PT EXPERIENCED AN MI ONE DAY POST STENT IMPLANT. PROLONGED HOSPITALIZATION WAS REQUIRED. THE PT IS REPORTED TO BE RECOVERED AND 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 CARDIOVASCULAR GALWAY NA 0000932603

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization ASPIRIN| ACE, LIPID LOWERING DRUGS, ASA| CLOPIDOGREL