BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161345 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02231
    Event Type
    Death
    Date Received
    September 12, 2008
    Date of Event
    February 7, 2008
    Report Date
    August 16, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. THE PATIENT WAS REPORTED TO HAVE ONE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE PROCEDURE. NO STAGED PROCEDURE WAS PLANNED. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS GREATER THAN 50% (LVEF>50%). THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS REPORTED TO BE: DE NOVO, 3.0 MM VESSEL DIAMETER, 8 MM LENGTH, A 90% STENOSIS, ANGLED (SEVERE END POINT=>90 DEGREES), AND TYPE B1. THE LESION WAS PRE-DILATED WITH A 2.5 X 12 MM BALLOON AT 6 ATM. A CYPHER SELECT PLUS 2.75 X 13 MM STENT WAS IMPLANTED AT 16 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS 0%. A SATISFACTORY RESULT WAS OBTAINED. THE PATIENT WAS DISCHARGED THE DAY OF THE PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS ASYMPTOMATIC AT THE ONE AND SIX-MONTH FOLLOW-UPS AND WAS CONTINUING HER MEDICAL REGIMEN. PLEASE NOTE THAT DEVICE (LOT # 13192928) 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 STUDY INDICATED THAT APPROXIMATELY SEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THERE WAS NO REPORTED EVIDENCE OF MYOCARDIAL INFARCTION, OR STENT THROMBOSIS. NO RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) OR CORONARY ARTERY BYPASS GRAFT SURGERY DONE PRIOR TO THE ADVERSE EVENT. NO AUTOPSY WAS PERFORMED. IT IS NOT KNOWN IF THE DEATH IS CARDIAC OR NON-CARDIAC. NO ADDITIONAL INFORMATION IS AVAILABLE. THE EVENT WAS REPORTED TO HAVE A POSSIBLE RELATIONSHIP TO THE PREVIOUSLY IMPLANTED CYPHER SELECT PLUS 2.75 X 13 MM STENT AND WAS UNRELATED TO THE STUDY PROCEDURE.

    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 13192928

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death 2.5 X 12 MM BALLOON