BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153066 · Received September 8, 2008

    Report

    Report Number
    9616099-2008-02179
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT THE PROCEDURE INCLUDED TREATMENT OF TWO LESIONS ONE IN THE LEFT ANTERIOR DESCENDING (LAD) AND ONE IN THE RIGHT CORONARY ARTERY (RCA). THE FIRST LESION TREATED WAS THE LESION IN THE LAD. THE VESSEL WAS RATHER TORTUOUS AND THE DE NOVO LESION WAS AT A BIFURCATION IN THE LAD AND THE DIAGONAL WAS 13MM LONG. THE LESION WAS SUCCESSFULLY PREDILATED WITH A FIRESTAR BALLOON CATHETER THEN THE PHYSICIAN CONTINUED TO STENT THE LESION WITH A 3.5X13MM CYPHER STENT. THE PROCEDURE WAS BEING PERFORMED WITHOUT AN ADDITIONAL WIRE DOWN THE DIAGONAL AS THE PHYSICIAN WAS CONFIDENT OF MAINTAINING PATENCY OF THE ARTERY. HOWEVER, AFTER STENTING, THE DIAGONAL WAS COMPROMISED; STENT POST DILATION WAS CONDUCTED BUT THE DIAGONAL REMAINED COMPROMISED. THE PHYSICIAN DECIDED THAT THE RESULTS WERE ACCEPTABLE AS THE DIAGONAL WAS A SMALL ARTERY AND CONTINUED TO STENT THE SECOND LESION IN THE RCA. THE PROCEDURE WAS COMPLETED SMOOTHLY WITHOUT FURTHER COMPLICATIONS. IMMEDIATELY AFTER THE EVENT, THE PATIENT WAS REPORTED TO BE STABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention FIRESTAR 2.0 X 10 BALLOON CATHETER