BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1656771 · Received April 7, 2010

    Report

    Report Number
    2953200-2010-00592
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    November 13, 2009
    Report Date
    March 10, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: DEATH, CVA/STROKE.

    Description of Event or Problem · 1

    PATIENT HAD 1 LESION TREATED. ONE ENDEAVOR RX STENT WAS IMPLANTED TO PROXIMAL LAD AS TREATMENT OF THE TARGET LESION. PATIENT WAS ASYMPTOMATIC AT 1 MONTH, 6 MONTH AND 1 YEAR FOLLOW-UP. APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE, INVESTIGATOR REPORTS PATIENT DEATH. INVESTIGATOR CLASSIFIED DEATH AS NON-SUDDEN NON-CARDIAC. INVESTIGATOR ASSESSED THE CAUSE OF DEATH AS STROKE. INVESTIGATOR NARRATIVE 'HOSPITALIZATION IN EMERGENCY ROOM FOR PARALYSIS ON LEFT BODY AND HIGH BLOOD PRESSURE'. INVESTIGATOR INDICATED THAT THE DEATH WAS NOT ASSOCIATED WITH AN MI AND THAT THERE WAS NO EVIDENCE OF STENT THROMBOSIS. PATIENT WAS TAKING ASA 24 HOURS BEFORE EVENT. INVESTIGATOR STATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000729436

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death