BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2800741 · Received October 23, 2012

    Report

    Report Number
    9612164-2012-01560
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    September 22, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULT - INHERENT RISK OF PROCEDURE (DEATH).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT STENT WAS IMPLANTED IN THE LCX DURING THE INDEX PROCEDURE. APPROXIMATELY 20 MONTHS POST THE INDEX PROCEDURE THE PATIENT HAD ANOTHER BRAND OF STENT IMPLANTED IN THE 1ST OM DUE TO CORONARY ARTERY STENOSIS. THE INVESTIGATOR CONFIRMED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED. IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY 27 MONTHS POST THE INDEX PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN HOWEVER THE INVESTIGATOR HAS CONFIRMED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT HAS BEEN CONFIRMED THAT THE PATIENT DIED DUE TO RESPIRATORY ARREST. THE DATE OF DEATH IS NOW REPORTED TO HAVE OCCURRED ONE DAY PRIOR TO THAT PREVIOUSLY REPORTED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R ASA AND CLOPIDOGREL