BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1081272 · Received July 21, 2008

    Report

    Report Number
    3003742446-2008-00130
    Event Type
    Death
    Date Received
    July 21, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 26, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT # 3003742446-2008-00129 AND # 3003742446-2008-00130.

    Description of Event or Problem · 1

    A COPY OF A VOLUNTARY MEDWATCH WAS RECEIVED. THE REPORT INDICATED THAT THE PT HAD A PTCA PROCEDURE AND HAD TWO CYPHER STENTS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (95% STENOSIS) AND STENTING OF THE INFERIOR BRANCH OF THE OBTUSE MARGINAL (95% STENOSIS). THE PT DID WELL POST-PROCEDURE, EXCEPT FOR SOME SHORTNESS OF BREATH (SOB), AND WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE. TWO-HOURS POST-DISCHARGE, WHILE SITTING AT HIS COMPUTER, THE PT EXPIRED. IT IS NOT KNOWN IF THE PT WAS ACCEPTED BY THE MEDICAL EXAMINER OR IF AN AUTOPSY WAS PERFORMED. AN AUTOPSY WAS NOT DONE AT THIS FACILITY, AS THE PT WAS NOT TRANSPORTED HERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 13379050

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death