BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1070007 · Received July 2, 2008

    Report

    Report Number
    9616099-2008-01665
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 5, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL, AS IT WAS DISCARDED BY THE FACILITY. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT REC'D INDICATED THAT DURING A CORONARY PROCEDURE, THE LESION WAS TREATED WITH A ROTABLATOR AND WAS SUBSEQUENTLY PREDILATED. THEN THE 3.0 X 28 MM CYPHER STENT WAS BEING DELIVERED; HOWEVER, THE DEVICE COULD NOT CROSS THE TARGET LESION DUE TO HEAVY CALCIFICATION. THE PHYSICIAN TRIED TO RE-DELIVER THE CYPHER SEVERAL TIMES AND THE DISTAL STRUTS OF THE STENT BECAME FLARED. THEREFORE, THE LESION WAS AGAIN TREATED WITH ROTABLATOR AND ANOTHER CYPHER (SIZE UNKNOWN) WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY INJURY OR ADVERSE EVENT TO THE PT. THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DE NOVO LESION WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS PRESENTING 90% STENOSIS.

    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 13348381

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR