BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2181174 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00821
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 5, 2011
    Report Date
    November 30, 2012
    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/MYOCARDIAL INFARCTION).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. APPROXIMATELY 4.5 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS RE-HOSPITALIZED. STENT THROMBOSIS OF TARGET VESSEL WAS CONFIRMED BY ACUTE CORONARY SYNDROME/ANGIOGRAPHIC CONFIRMATION OF STENT THROMBOSIS OR OCCLUSION. THE PATIENT ALSO SUFFERED AN MI. THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENTS WERE POSSIBLY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THAT THE PREVIOUSLY REPORTED STENT THROMBOSIS EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. THE PATIENT WAS NOT ON DAPT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001019761

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LIPID LOWERING DRUGS| BETA-BLOCKERS| ASA| CA++ ANTAGONIST| CLOPIDOGREL