BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1170730 · Received September 15, 2008

    Report

    Report Number
    9616099-2008-02251
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 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 PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE, THE EVALUATION HAS NOT BEEN COMPLETED. 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

    THE REPORT RECEIVED INDICATED THAT DURING A PROCEDURE TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY; THE GUIDING CATHETER WAS ENGAGED TO THE TARGET VESSEL THEN PRE-DILATION WAS CONDUCTED. BECAUSE THE VESSEL HAD AN S-SHAPED FLEXION AT THE OSTIUM OF LEFT CIRCUMFLEX (LCX), A WIRE WAS INSERTED TO STRAIGHTEN IT. THEN THE 2.5X13MM CYPHER WAS BEING DELIVERED, HOWEVER, IT DID NOT ADVANCED TO LCX BUT TENDED TO GO INTO THE LEFT ANTERIOR DESCENDING. THEREFORE, THE PHYSICIAN WITHDREW THE CYPHER OUT OF THE PATIENT AND FOUND THE PROXIMAL END OF THE STENT TO BE FLARED. THE CYPHER WAS REPLACED WITH A DRIVER STENT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. FURTHER INFORMATION INDICATED THE TARGET LESION WAS THE PROXIMAL CIRCUMFLEX ARTERY. THE LESION WAS A DE NOVO, MODERATELY CALCIFIED AND HIGHLY TORTUOUS. THERE WAS 90% STENOSIS. FEMORAL APPROACH HAD BEEN CHOSEN FOR THE PROCEDURE. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES ON THE DEVICE PRIOR TO USE.

    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 13408329

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATHETER| DRIVER 2.5/12MM STENT| GUIDEWIRE: TGV