BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1253269 · Received December 5, 2008

    Report

    Report Number
    2953200-2008-01132
    Event Type
    Death
    Date Received
    December 5, 2008
    Date of Event
    September 30, 2008
    Report Date
    November 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INHERENT RISK OF PROCEDURE, (DEATH, MI)

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED IN THE MID RCA. IT IS REPORTED THAT FIFTEEN DAYS POST INITIAL IMPLANT THAT THE PATIENT SUFFERED A SUDDEN DEATH. INVESTIGATOR REPORTED THAT THE PATIENT WASN'T FEELING GOOD AT HOME AND THE PATIENT'S GENERAL PRACTITIONER CAME BY. WHILE THE GENERAL PRACTITIONER WAS PRESENT, IT IS REPORTED THAT THE PATIENT WENT INTO ATRIAL FIBRILLATION. THE GENERAL PRACTITIONER ATTEMPTED TO RESUSCITATE, BUT THE PATIENT DIED AT HOME. IT IS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY STENT. INVESTIGATOR HAS INDICATED THAT DEATH WAS ASSOCIATED WITH A MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000534176

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death