BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1002598 · Received February 8, 2008

    Report

    Report Number
    9616099-2008-00307
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 27, 2007
    Report Date
    January 15, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ONE NON-STERILE CYPHER 3.50X13 MM WAS REC'D COILED INSIDE A PLASTIC BAG. THE PROXIMAL AND DISTAL END OF THE STENT WAS REC'D WITH THE STRUTS UPLIFTED. NO MORE ANOMALIES WERE FOUND. STENT CROSSING PROFILE TO THE MIDDLE SECTION OF THE STENT WAS PERFORMED, AND THE RESULT WAS FOUND TO BE WITH IN SPECS. SENT CROSSING PROFILE TO THE DISTAL AND PROXIMAL ENDS COULD NOT BE PERFORMED, SINCE THESE ENDS WERE UPLIFTED. NO FURTHER ANALYSIS WAS PERFORMED. THE STRUT UPLIFT FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. HOWEVER, THE EXACT CAUSE OF THIS FAILURE COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. THIS FAILURE COULD BE RELATED TO PROCEDURAL FACTORS. NO CORRECTIVE ACTION WAS TAKEN SINCE THE CAUSE OF THIS FAILURE DOES NOT APPEAR TO BE MANUFACTURING RELATED. ALTHOUGH NOT REPORTED STRUT UPLIFT CONFIRMED THROUGH FAILURE ANALYSIS. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE DHR AND THE FAILURE ANALYSIS, THERE IS NOT INDICATION THAT THIS ISSUE IS A RESULT OF THE MFG PROCESS.

    Description of Event or Problem · 1

    THE PT WAS A FEMALE. THE TARGET LESIONS WERE IN THE PROXIMAL RIGHT CORONARY ARTERY AND LEFT ANTERIOR DESCENDING ARTERY. THE PROX RCA HAD A HIGH TAKEOFF AND WAS FLEXED. THE LESION WAS A DE NOVO. THE VESSEL WAS CALCIFIED AND SLIGHTLY TORTUOUS. THERE WAS 90% STENOSIS. INITIALLY, 2 CYPHERS (DETAILS ARE UNK) WERE IMPLANTED AT LAD WITHOUT PROBLEM. THE PRE-DILATION WITH A BALLOON (SPEEDER 3.0/10MM) WAS CONDUCTED AT THE PROX RCA AND A CYPHER (3.5/13MM) WAS DELIVERED TO THE TARGET LESION, BUT IT DID NOT CROSS, AND SO THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH THE IMPLANT OF A TAXUS (3.5/12MM). THERE WAS NO PT INJURY REPORTED.

    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 13291466

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GUIDE WIRE: ATHLETESOFTGT| SHEATH: ABBOTT| GUIDE CATHETER: LAUNCHER JR3.5