BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR CORONARY DRUG-ELUTING STENT

    MDR report key: 1656764 · Received April 9, 2010

    Report

    Report Number
    2953200-2010-00620
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    January 30, 2010
    Report Date
    March 11, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: GI BLEED, DEATH.

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 9 MM LENGTH ENDEAVOR DRUG-ELUTING CORONARY STENT WAS IMPLANTED IN A PT FOR THE TREATMENT OF AN UNK LESION APPROXIMATELY 48 MONTHS AGO. IT WAS REPORTED 46 MONTHS POST INITIAL STENT IMPLANT THAT THE PT WAS ADMITTED DUE TO LOW HEMOGLOBIN AND HEMATOCRIT. THE PT RECEIVED 2 UNITS OF PACKED RBC'S. AS PER THE INVESTIGATOR, THE BLEEDING WAS REPORTED TO NOT BE RELATED TO THE DEVICE, DRUG, OR THE PROCEDURE. IT WAS REPORTED APPROXIMATELY 48 MONTHS POST INITIAL STENT IMPLANT THAT THE PT HAD EXPIRED AFTER BEING IN HOSPITAL FOR A FEW WEEKS. NO FURTHER DETAILS HAVE BEEN OBTAINED. AS PER THE INVESTIGATOR, THE DEATH WAS REPORTED TO NOT BE RELATED TO THE DEVICE, DRUG, OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC CARDIOVASCULAR NA 435733-0019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death