BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2040812 · Received March 24, 2011

    Report

    Report Number
    9612164-2011-00106
    Event Type
    Death
    Date Received
    March 24, 2011
    Date of Event
    July 3, 2010
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID LAD AND ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT IMPLANTED TO THE 1ST OBTUSE MARGINAL. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY, 6 MONTH FOLLOW-UP. PATIENT WAS REPORTED TO HAVE SUFFERED A SPONTANEOUS INTRAOCULAR BLEED APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE. INVESTIGATOR ASSESSED THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 1 YEAR AND 1.5 YEAR FOLLOW UP. PATIENT DEATH IS REPORTED TO HAVE OCCURRED APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE. DEATH WAS ASSESSED AS A NON-SUDDEN DEATH. NON OTHER INFORMATION IS CURRENTLY AVAILABLE. (REF MFR # 9612164-2011-00107)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000534179

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death CLOPIDOGREL| ASPIRIN