BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 842155 · Received April 25, 2007

    Report

    Report Number
    9616099-2007-00750
    Event Type
    Death
    Date Received
    April 25, 2007
    Date of Event
    March 13, 2005
    Report Date
    April 2, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION FOR THE PROCEDURE WAS THE PROXIMAL CIRCUMFLEX. THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, CALCIFIED, 19.01 MM IN LENGTH, VESSEL DIAMETER OF 4.13 MM, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 3.5X15 MM BALLOON AT 12 ATM FOR 30 SEC. A CYPHER 3.5 X 18 MM STENT WAS IMPLANTED AT 20 ATM FOR 30 SEC. THE STENT WAS POST-DILATED WITH A 3.5 X 15 MM BALLOON AT 26 ATM FOR 30 SEC. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 34%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS INCLUDED IN A CLINICAL STUDY. APPROXIMATELY THREE (3) MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED AT HOME. THERE WAS NO TREATMENT OR CORONARY ANGIOGRAPHY DONE. AN AUTOPSY WAS NOT DONE. THE PHYSICIAN'S COMMENT WAS THAT THE POSSIBLE THROMBOTIC EVENT MAY HAVE OCCURRED BECAUSE OF THE PATIENT'S HIGH RISK FACTORS INCLUDING DIABETES AND HEART DISEASE. THE EVENT WAS SUDDEN DEATH.

    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 I1104076

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death TICLID| 3.5 X 15 MM BALLOON| ASPIRIN