BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1031150 · Received April 17, 2008

    Report

    Report Number
    9616099-2008-01015
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    November 1, 2007
    Report Date
    April 7, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE SAME PRODUCT DISTRIBUTED IN THE UNITED STATES. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PT REPORTED UNDER MFG NUMBER 9616099-2008-01015 AND 9616099-2008-01016. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE CORDIS CLINICAL STUDY INDICATING THAT A PT DIED OF AN UNK CAUSE ONE DAY AFTER RECEIVING TWO CYPHER STENTS IN THE SUPERFICIAL FEMORAL ARTERY. NO INFO WAS PROVIDED REGARDING THE PT OR THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PT HAD A WORSENING RUTHERFORD SCORE RATED AS MODERATE, AND A GROIN HEMATOMA WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA A0505102

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death