BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083784 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01845
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    January 21, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    ONE-YEAR POST IMPLANT PROCEDURE, THE STENT WAS FOUND FRACTURED. THE REPORT RECEIVED FROM THE CLINICAL STUDY IN KOREA. THE INDEX PROCEDURE WAS CONDUCTED IN THE ONSET OF STABLE ANGINA PECTORIS, BASELINE ELECTROCARDIOGRAM WAS CONDUCTED. THE PT HAD BEEN DIAGNOSED WITH ONE VESSEL DISEASE, THE TARGET WAS A LESION IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD). DURING THE INDEX PROCEDURE, THE 2.75X33MM CYPHER STENT WAS DEPLOYED AT 10 ATMOSPHERES (ATM) FOLLOWED BY POST-DILATION. THERE WAS NO REPORT OF COMPLICATIONS ENCOUNTERED DURING THE PROCEDURE. ONE-DAY POST INDEX, THE PT WAS DISCHARGED. THERE WERE NO INJURIES OR ADVERSE EVENTS REPORTED FOR THE PATIENT. THE PT WAS FOLLOWED UP, ONE MONTH, 6 MONTHS, AND ONE YEAR POST STENTING PROCEDURE. THE PATIENT'S ANGINA STATUS REMAINED ASYMPTOMATIC AND THE PATIENT CONTINUED ON THE DISCHARGED MEDICATION. HOWEVER, DURING THE ONE YEAR FOLLOW UP, AN ELECTROCARDIOGRAM (ECG) WAS CONDUCTED, AND THE STENT WAS FOUND FRACTURED. THERE WAS NO INDICATION OF ANY STENT SEPARATION NOR WAS THERE ANY INDICATION OF IN-STENT RESTENOSIS. THE VESSEL'S DISTAL FLOW WAS GOOD; NO TREATMENT WAS PERFORMED. THE PATIENT DID NOT PRESENT ANY ADVERSE EVENTS.

    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 13191789

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR CLOPIDOGREL| BETA BLOCKERS| MEDICATION AT: BASELINE: ASPIRINE| INTRAPROCEDURE: UNFRACTIONATED HEPARINE| CLOPIDOGREL| DISCHARGE: ASPIRIN| CLOPIDOGREL| STATINS| POST PROCEDURE: ASPIRIN