BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 1050222 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00352
    Event Type
    Death
    Date Received
    May 22, 2008
    Date of Event
    February 25, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: DEATH, LACK OF INFO, NO AUTOPSY REPORT.

    Description of Event or Problem · 1

    THERE WERE FIVE STENTS IMPLANTED IN THE PT TO TREAT FOUR LESIONS. THERE WERE A TOTAL OF FIVE STENTS USED IN THE PT. (REF #S MDR2953200-2008-00350 THRU MDR2953200-2008-00354). THERE WAS ONE ENDEAVOR STENT (2.5X18 MM) IN THE MID RCA, ONE ENDEAVOR STENT (3.0X30 MM) PROXIMAL LEFT CIRCUMFLEX, ONE ENDEAVOR STENT (4.0X12 MM) IN THE PROXIMAL RCA, AND TWO ENDEAVOR STENTS WERE IMPLANTED (3.5X15MM AND 3.0X24MM) IN THE 1ST OBTUSE MARGINAL VESSEL. THERE WERE NO ISSUES REPORTED RELATING TO THE IMPLANT PROCEDURES. IT WAS REPORTED THAT THE PT DIED APPROX 35 DAYS POST STENT IMPLANT. THE INVESTIGATOR REPORTED THAT IT WAS A SUDDEN DEATH. IT WAS REPORTED THAT THE DEATH WAS NOT ASSOCIATED WITH AN MI OR THROMBOSIS. AN AUTOPSY REPORT IS NOT AVAILABLE. THE INVESTIGATOR REPORTED THAT THE DEATH WAS NOT RELATED TO THE STUDY STENT OR STUDY PROCEDURES. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX NIQ MEDTRONIC CARDIO VASCULAR GALWAY NA 0000353469

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death