BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2211869 · Received August 8, 2011

    Report

    Report Number
    9612164-2011-00897
    Event Type
    Death
    Date Received
    August 8, 2011
    Date of Event
    February 18, 2011
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH, DUE TO CARDIAC ARREST).

    Description of Event or Problem · 1

    PT RECEIVED A 2.5MM DIAMETER X 30MM LENGTH AND A 3.0MM DIAMETER X 15MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE LAD DURING INDEX PROCEDURE WITH NO ISSUE REPORTED. IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, THE PT WAS MEDICALLY TREATED FOR ABDOMINAL PAIN AND URINARY TRACT INFECTION. IT WAS REPORTED THAT, APPROXIMATELY 1 YEAR POST STENT IMPLANT THE PT DIED DUE TO CARDIAC ARREST. INVESTIGATOR REPORTED THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT AND PROCEDURE. (REF MFR # 9612164201100896 & 00897).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001444542

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death DUAL ANTIPLATELET THERAPY