BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3112996 · Received May 15, 2013

    Report

    Report Number
    9612164-2013-00537
    Event Type
    Death
    Date Received
    May 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    May 19, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: DEATH, PULMONARY EDEMA. CONCLUSIONS: DEATH,PULMONARY EDEMA. (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN THE LCX. APPROXIMATELY 14.5 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. CAUSE OF DEATH WAS HEART FAILURE, ACUTE PULMONARY EDEMA AND RENAL FAILURE. INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL CAUSE OF DEATH ARE COPD, SHOCK AND RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214427 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002379223

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death CLOPIDOGREL