BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1081983 · Received July 22, 2008

    Report

    Report Number
    9616099-2008-01820
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE CYPHER SELECT COULD NOT CROSS THE LESION AND SUBSEQUENTLY THE CATHETER SHAFT SEPARATED. THE INTENDED PROCEDURE WAS INTERVENTION TO THE RIGHT CORONARY ARTERY. THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE HIGHLY TORTUOUS DISTAL LESION. AFTER REPEATED ATTEMPTS TO CROSS THE LESION, THE SHAFT SEPARATED 57 CM FROM THE HUB. THE SEPARATED SDS WAS RETRIEVED COMPLETELY WITHOUT ANY ADVERSE CONSEQUENCE TO THE PATIENT.

    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 13363056

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK