BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063653 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01534
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT, IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED STENT DELIVERY SYSTEMS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Description of Event or Problem · 1

    DURING A STENTING PROCEDURE IN THE LEFT MAIN, FOLLOWING PREDILATATION, THE CYPHER SDS BALLOON WOULD NOT INFLATE AT THE LESION SITE. THE STENT DID NOT COME OFF THE BALLOON AT ANY TIME. ANOTHER CYPHER SDS WAS USED SUCCESSFULLY. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT. THE PRODUCT IS SAID TO BE AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE (WHICH IS INDICATED AS "OTHER"). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS DE MEXICO NA 13364646

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR MAVERICK 2X15 PREDILATATION BALLOON