BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1081981 · Received July 22, 2008

    Report

    Report Number
    9616099-2008-01816
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Report Date
    July 11, 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

    THE STENT SYSTEM IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, THE DEVICE HAS NOT BEEN RETURNED AS OF TO DATE (WHICH IS CODED AS "OTHER" ). ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING STENTS DISTRIBUTED IN THE US.

    Description of Event or Problem · 1

    DURING A CORONARY STENTING PROCEDURE, THE CYPHER STENT DELIVERY CATHETER BALLOON RUPTURED. THE TARGET SITE WAS THE MID RIGHT CORONARY ARTERY LESION, WHICH WAS CHARACTERIZED AS DE NOVO, HEAVILY CALCIFIED AND MODERATELY TORTUOUS WITH 100% STENOSIS (CHRONIC TOTAL OCCLUSION). A GUIDEWIRE WAS ABLE TO CROSS THE LESION; HOWEVER A PREDILATATION BALLOON CATHETER WAS UNABLE TO CROSS THE LESION DUE TO THE HEAVY CALCIFICATION. THEREFORE, ROTABLATOR AND INVASCULAR ULTRASOUND (IVUS) WERE CONDUCTED AND PREDILATION WAS COMPLETED WITH A POWERED LACROSSE 2.75X15MM HIGH-PRESSURE BALLOON. THE CYPHER 3.00X33MM STENT WAS DELIVERED TO THE LESION WITHOUT DIFFICULTY; HOWEVER, THE BALLOON COULD NOT BE INFLATED. A BALLOON RUPTURE WAS SUSPECTED, AND THEREFORE, ANOTHER CYPHER STENT WAS USED AND IMPLANTED AT THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT 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 13396912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IKAZUCHI 1.5/10MM| AND POWERED LACROSSE 2.75/15MM BALLOON CATHETERS| ATHLETE GT SOFT| EVEREST 30 INDEFLATOR| CONQUESTPRO| AND TORNUS GUIDEWIRES