BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1041234 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01258
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 15, 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 99%, SLIGHTLY CALCIFIED, DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) BRANCH. THE PATIENT WAS INITIALLY ADMITTED WITH AN ACUTE MYOCARDIAL INFARCTION. THE LESION WAS PRE-DILATED. THEN A 2.5 X 23 MM CYPHER STENT WAS BEING INFLATED, BUT THE BALLOON RUPTURED AT 12 ATMS WHEN PRESSURIZED FOR 30 SECONDS. BECAUSE CONTRAST MEDIUM LEAKAGE WAS OBSERVED, THE BALLOON RUPTURE WAS CONFIRMED. THEREFORE, THE PHYSICIAN STOPPED THE USE OF THE CYPHER AND IMPLANTED A 2.5 X 24 MM TAXUS STENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    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 13350750

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR A 7F JL4 SH LAUNCHER GUIDING CAHTETER| THE FOLLOWING PRODUCTS WERE USED DURING THE| A 2.5 X 10 MM LACROSSE BALLOON CATHETER| PROCEDURE: A RUNTHROUGH GUIDEWIRE| A 2.0 X 15 MM BALLOON CAHTETER