BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR

    MDR report key: 2335213 · Received November 14, 2011

    Report

    Report Number
    9612164-2011-01410
    Event Type
    Death
    Date Received
    November 14, 2011
    Date of Event
    May 4, 2011
    Report Date
    October 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (B)(4) INHERENT RISK OF PROCEDURE (MI). (B)(4) PATIENT'S CONDITION PREDISPOSED EVENT (DEATH DUE TO LUNG CANCER) (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION.

    Description of Event or Problem · 1

    THERE WERE THREE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE MID LEFT ANTERIOR DESCENDING, ONE IN THE DISTAL LEFT ANTERIOR DESCENDING AND ONE IN THE 1ST DIAGONAL BRANCH. ADVERSE EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. IT WAS REPORTED THAT AN ARC DEFINED MI OCCURRED ONE DAY POST STENT IMPLANT IN THE TERRITORY OF THE TARGET VESSEL. NO FURTHER DETAILS ARE AVAILABLE. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTHS, 1 YEAR, 1.5YRS, 2YRS AND 2.5 YEAR FOLLOW UP'S. IT IS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 3 YEARS POST INDEX PROCEDURE AND IT WAS REPORTED THAT THE CAUSE OF DEATH WAS LUNG CANCER. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY (B)(4). IT WAS REPORTED THAT THE DEATH WAS NOT ASSOCIATED WITH A MYOCARDIAL INFRACTION AND THERE WAS NO EVIDENCE OF STENT THROMBOSIS. EVENT WAS IDENTIFIED BY (B)(4) AND DEEMED TO BE CONSISTENT WITH AN MI. IT WAS REPORTED THAT AN MI OCCURRED ONE DAY BEFORE THE PATIENT DEATH. NO FURTHER DETAILS ARE AVAILABLE. (REF MFR # 9612164-2011-01409, 9612164-2011-01410 AND 9612164-2011-01411)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000659205

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death