BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1964159 · Received January 13, 2011

    Report

    Report Number
    2953200-2011-00096
    Event Type
    Death
    Date Received
    January 13, 2011
    Date of Event
    March 2, 2010
    Report Date
    December 14, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (DEATH).

    Description of Event or Problem · 1

    THE PT HAD 1 ENDEAVOR SPRINT 3.0X 24MM RX DRUG-ELUTING STENT IMPLANTED IN THE DISTAL RCA DURING THE INDEX PROCEDURE WITH NO ISSUES REPORTED. IT WAS REPORTED THAT AT THE 30 DAY F/U THE PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS HOWEVER NO F/U WAS CARRIED AT THE 6 MONTH F/U AS THE PT WAS UNAVAILABLE. IT WAS CONFIRMED THAT APPROX 12 MONTHS POST THE INDEX PROCEDURE THE PT HAD DIED HOWEVER NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death