BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212586 · Received October 24, 2008

    Report

    Report Number
    9616099-2008-02529
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    STENT THROMBOSIS AND STENT FRACTURE IDENTIFIED THIRTEEN MONTHS POST IMPLANT. THE REPORT RECEIVED INDICATED THAT A 2.5X33 CYPHER STENT WAS IMPLANTED IN THE PATIENT'S MID LEFT ANTERIOR DESCENDING. APPROXIMATELY, THIRTEEN MONTHS POST IMPLANT, THE PATIENT RETURNED TO THE HOSPITAL AND A VERY LATE STENT THROMBOSIS WAS CONFIRMED; THERE WAS NO BLOOD FLOW FROM THE PROXIMAL AREA OF THE STENT. THE PHYSICIAN CONDUCTED INTRAVASCULAR ULTRASOUND AND EXPANDED WITH A HIGH-PRESSURE BALLOON THE FRACTURED PART OF CYPHER. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention