BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3012571 · Received March 20, 2013

    Report

    Report Number
    9612164-2013-00314
    Event Type
    Death
    Date Received
    March 20, 2013
    Date of Event
    September 1, 2012
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS AND CONCLUSION: INHERENT RISK OF PROCEDURE - (DEATH, PULMONARY EDEMA). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE PAV. IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS POST THE INDEX PROCEDURE, THE PATIENT DIED DUE TO PULMONARY EDEMA. DEATH WAS CONFIRMED BY THE CLINICAL EVENTS COMMITTEE TO BE A CARDIAC DEATH. THE INVESTIGATION HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116521 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005690993

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death