BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1253268 · Received December 5, 2008

    Report

    Report Number
    2953200-2008-01131
    Event Type
    Death
    Date Received
    December 5, 2008
    Date of Event
    September 18, 2007
    Report Date
    November 5, 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
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INHERENT RISK OF PROCEDURE (DEATH).

    Description of Event or Problem · 1

    TWO ENDEAVOR RX DRUG-ELUTING STENTS WERE SUCCESSFULLY IMPLANTED, OVERLAPPING, IN THE PROXIMAL RCA. (MFR REPORT# 2953200-2008-01130-01131). AT 30 DAY, 6 MONTH AND 12 MONTH FOLLOW-UP PATIENT WAS ASYMPTOMATIC. IT IS REPORTED THAT ONE YEAR AND 10 DAYS POST INITIAL STENT IMPLANT THE PATIENT SUFFERED A SUDDEN DEATH. IT IS REPORTED THAT DEATH OCCURRED SUDDENLY, OUT OF HOSPITAL. ACUTE MI AND STENT THROMBOSIS WERE NOT RULED OUT. AUTOPSY REPORT IS NOT AVAILABLE. THE INVESTIGATOR HAS STATED THAT THERE WAS A POSSIBLE/PROBABLE RELATIONSHIP TO THE ENDEAVOR STENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death