BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 969748 · Received December 21, 2007

    Report

    Report Number
    9616099-2007-02561
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    December 8, 2007
    Report Date
    December 17, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE DISTAL CIRCUMFLEX. THE VESSEL WAS A DE-NOVO AND ECCENTRIC LESION. LESION CLASSIFICATION OF THE VESSEL WAS A TYPE B2. THE LESION LENGTH AWS 15MM AND VESSEL DIAMETER WAS 3.0MM. PRE-DILATATION WAS CONDUCTED WITH A 3.0X20MM BALLOON AT 7ATM FOR 30 SECS. A 3.0X18MM CYPHER STENT WAS DEPLOYED AT 12 ATMS FOR 30 SECS. POST-DILATATION WAS CONDUCTED WITH A 3.0X14MM BALLOON AT 8 ATMS FOR 30 SECS. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WAS III. ACTIVATED CLOTTING TIME (ACT) WAS NOT MEASURED. THERE WAS NO ABNORMALITY ON CREATINE PHOSPHOKINASE (CPK), AFTER THE PROCEDURE. FOUR DAYS LATER THE RESULT OF THE STRESS ELECTROCARDIOGRAM WAS NEGATIVE. THE NEXT DAY, ALTHOUGH THE PT WAS SCHEDULED TO BE DISCHARGED FROM THE HOSPITAL A WEEK LATER, THE PT WAS EAGER TO GO HOME AND SO THE PT WAS DISCHARGED FROM THE HOSPITAL IN THE MORNING. HOWEVER, THE PT WAS FOUND TO BE DECEASED AT HIS HOME IN THE AFTERNOON. THE PT WAS DELIVERED TO THE HOSPITAL BUT HAD ALREADY WENT INTO CARDIAC-RESPIRATORY ARREST APPROX. 2-3 HRS PRIOR TO HIS ARRIVAL. THE AUTOPSY WAS NOT PERFORMED. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THIS EVENT WAS UNK BECAUSE THIS IS SUDDEN DEATH AND SO UNK IF IT IS RELATED TO CYPHER'S PROBLEM. HOWEVER, THE TARGET LESION AT THE DISTAL CIRCUMFLEX WAS TOO SHORT FOR IT TO BECOME THE CAUSE OF THE DEATH. ALSO, THE PT EXPERIENCED BRAIN INFARCTION TWICE THIS YEAR BUT STILL CONTINUED SMOKING AND DRINKING ALCOHOL.

    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 13302912

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death