BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR CORONARY DRUG-ELUTING STENT

    MDR report key: 1673189 · Received April 30, 2010

    Report

    Report Number
    2953200-2010-00759
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    May 29, 2009
    Report Date
    April 2, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL RESULTS: DEATH.

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR DRUG-ELUTING CORONARY STENT WAS SUCCESSFULLY IMPLANTED IN AN UNK LESION. IMPLANT INFO IS UNK. APPROXIMATELY 39 MONTHS POST INDEX PROCEDURE, THE PT WAS BROUGHT IN EMERGENTLY WITH CHEST PAIN AND SHORTNESS OF BREATH. CARDIAC CATHETERIZATION WAS OFFERED, BUT THE PT DEFERRED. THE PT WAS DISCHARGED TWO DAYS LATER. THE FOLLOWING DAY, IT WAS REPORTED THAT THE PT WAS BROUGHT IN EMERGENTLY IN FULL CARDIAC ARREST. THE PT EXPIRED. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE DEVICE, DRUG OR INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC CARDIOVASCULAR NA 542940-0144

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death