BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053638 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01398
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING, HOWEVER, AS OF TO DATE THE EVAL HAS NOT BEEN COMPLETED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE 3.50X13MM STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION. THE PHYSICIAN EXCHANGED THE DEVICE FOR A SIMILAR UNIT AND THE PROCEDURE WAS COMPLETED; THERE WAS NO REPORT OF INJURY TO THE PT. THE PRODUCT WAS RETURNED FOR EVAL; HOWEVER, UPON RETURN, THE STENT ON THE DEVICE WAS RECEIVED DETACHED FROM THE BALLOON AND THE STENT STRUTS WERE FLARED. FURTHER ATTEMPTS TO CLARIFY HOW THE PROBLEMS WITH THE STENT OCCURRED WERE MADE; HOWEVER, THERE WAS NO OTHER INFO AVAILABLE.

    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 13347586

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK