BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1022099 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00776
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A 75% DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING BRANCH. A 3.0 X 18MM CYPHER WAS DELIVERED TO THE LESION BY DIRECT STENTING, AS THE VESSEL WAS NOT CALCIFIED. THE STENT DELIVERY SYSTEM WAS INFLATED TO 14ATM AT THE LESION AND THE STENT WAS IMPLANTED. THEN, THE STENT DELIVERY SYSTEM WAS PULLED SLIGHTLY TO THE PROXIMAL END AND INFLATED AGAIN AT 14ATM. HOWEVER, THE PHYSICIAN FOUND CONTRAST MEDIUM TO BE LEAKING AND THE BLOOD WAS FLOWING INTO THE INFLATION DEVICE. BECAUSE THE STENT WAS ALREADY IMPLANTED AT THE TARGET LESION, THE PROCEDURE WAS FINISHED. THE STENT WAS POST-DILATED, HOWEVER, THE REASON IS UNKNOWN.

    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 13320815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK