BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053627 · Received May 23, 2008

    Report

    Report Number
    3003742446-2008-00087
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    April 29, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT REPRESENTS NOTIFICATION OF FOUR DEVICES THAT ARE ALSO NOT AVAILABLE FOR TESTING AND EVAL. PLEASE NOTE THAT THE DEVICE CATALOG AND LOT NUMBERS ARE NOT CURRENTLY KNOWN. UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN THEM. EFFORTS ARE ONGOING TO OBTAIN FURTHER DETAILS OF THE PT HISTORY, INDEX PROCEDURE AND ADVERSE EVENTS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THIS PT WITH (4) UNIDENTIFIED CYPHER STENTS IN UNIDENTIFIED VESSELS, REPORTED THAT THE STENTS COLLAPSED AND HE HAD TO HAVE (3) SURGERIES TO GET THEM OUT INCLUDING OPEN HEART SURGERY. NO DATES ARE KNOWN FOR THESE SURGERES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R