BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032591 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01037
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    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. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A 3.5 X 23MM CYPHER STENT WAS FLUSHED WITH HEPARIN. WHEN THE 3.5 X 23MM CYPHER STENT WAS REMOVED FROM ITS PROTECTIVE SHEATH THE PHYSICIAN CONFIRMED THAT THE PROXIMAL END OF THE STENT WAS FLARED, PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THEREFORE, THE PHYSICIAN COMPLETE THE PROCEDURE WITH ANOTHER CYPHER OF THE SAME SIZE.

    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 13308086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA THE FOLLLOWING PRODUCTS WERE USED DURING THE| PRODUCT: NEO'S SOFT GUIDE WIRE| CATHETER AND HIRYU BALLOON CATHETER.