BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1140560 · Received August 28, 2008

    Report

    Report Number
    3003742446-2008-00168
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE, THE EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE THE BALLOON ON THE 3.00 X 8.00 MM CYPHER DID NOT INFLATE. THE PROBLEM WAS IDENTIFIED DURING THE FIRST INFLATION ATTEMPT, A MAXIMUM PRESSURE OF 10 ATMOSPHERES WAS APPLIED; HOWEVER, THE BALLOON DID NOT APPEAR TO INFLATE. AFTER ENCOUNTERING THE PROBLEM, THE DEVICE WAS REMOVED AND REPLACED BY A SECOND CYPHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY INJURY TO THE PATIENT. FURTHER INFORMATION INDICATED THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING; THE VESSEL WAS SLIGHTLY TORTUOUS. THE CONTRAST TO SALINE RATIO USED WAS 20:30. THERE WAS NO LEAKAGE NOTED ON THE DEVICE AND DURING THE PREPPING STAGES THERE WERE NO ANOMALIES NOTED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 13409399

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ABBOT 20/30 INDEFLATOR