BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1190603 · Received October 6, 2008

    Report

    Report Number
    9616099-2008-02396
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION FOR THE PROCEDURE WAS THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS REPORTED TO BE: AN IN-STENT RESTENOSIS (ISR) OF ONE OF THREE PREVIOUSLY IMPLANTED TAXUS STENTS, MODERATELY CALCIFIED, NOT TORTUOUS, AND A 75% STENOSIS. THE PATIENT HAD THREE TAXUS STENTS IMPLANTED IN THE PROXIMAL RCA LESION IN OVERLAPPING FASHION: A 3.5 X 12 MM, A 3.5 X 20 MM, AND A 3.5 X 12MM. THE ISR WAS NOTED TO BE IN THE MOST PROXIMAL 3.5 X 12 MM TAXUS STENT. THE DATE OF THE IMPLANTATION OF THE THREE TAXUS STENTS WAS NOT KNOWN. THE LESION WAS PRE-DILATED WITH A 3.0 X 15 MM VOYAGER BALLOON AT 14 ATM FOR 20 SEC. PLEASE NOTE THAT DEVICE (LOT# 13431884) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION AFTER PRE-DILATING THE LESION, A CYPHER 3.5 X 13 MM STENT WAS IMPLANTED AT 20 ATM. DURING THE INFLATION, THE PRESSURE DECREASED INDICATING A POSSIBLE BALLOON BURST OF THE STENT DELIVERY SYSTEM (SDS) BALLOON. THE SDS WAS REMOVED FROM THE PATIENT, AND THE STENT WAS POST-DILATED WITH A 3.75 X 14 MM AVION HP BALLOON/DETAILS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN'S COMMENT REGARDING THE PROBLEM, WAS THAT THE BALLOON WAS INFLATED TO 20 ATM FOR COMPLETE EXPANSION OF THE STENT.

    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 13431884

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R GC: BOSTON/MACH1 FR4SH 6F,| INFLATION DEVICE: MEDTRONIC/EVEREST| <POST> ST JUDE MEDICAL/AVION| CSI: TERUMO/6F 16CM M COAT| GW: ACS/WHISPER LS| BC: <PRE> ABOTT/VOYAGER