BEUDAMED
    FDA Adverse Event Death Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 1210663 · Received October 23, 2008

    Report

    Report Number
    9616099-2008-02515
    Event Type
    Death
    Date Received
    October 23, 2008
    Date of Event
    December 5, 2007
    Report Date
    September 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. IN ADDITION, THIS LATE REPORT WAS DUE TO RECONCILIATION OF EVENTS SUBMITTED BY THIS STUDY.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, TWO YEARS AFTER THE BASELINE PROCEDURE, THE PATIENT EXPERIENCED SUDDEN DEATH. ADDITIONAL DETAILS WERE NOT AVAILABLE. THIS PATIENT WAS RANDOMIZED TO THE BARE METAL ARM OF THE STUDY. PCI WAS PERFORMED ON A TAPERED LESION IN THE 1ST OBTUSE MARGINAL BRANCH WITH NO COLLATERALS. TIMI 0 FLOW WAS RECORDED PRE-PROCEDURE. A 2.75X33MM BX SONIC STENT WAS DEPLOYED AT UNKNOWN INFLATION PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO NA 40405701

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| L BETABLOCKERS| CA ANTAGONISTS| ASPIRIN