BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2894059 · Received January 3, 2013

    Report

    Report Number
    3003742446-2013-00004
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    September 24, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(6) INDICATED THAT A PATIENT EXPIRED DUE TO CARDIAC ARREST APPROXIMATELY (B)(6) POST INDEX PROCEDURE. NO ADD'L INFO IS AVAILABLE YET. THIS WAS AN UNKNOWN PATIENT. AT THE TIME OF INDEX PROCEDURE, A 3.0 X 13 MM AND 2.5 X 8 MM CYPHER STENTS WERE BEING PLACED IN THE MLAD AND DCX. THE INVESTIGATOR CONSIDERED THE EVENT WAS NOT RELATED TO THE STUDY DRUG, STENT, OR PROCEDURE. THE CYPHER STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00004 AND 3003742446-2013-00005.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(6) INDICATED THAT A PATIENT EXPIRED DUE TO CARDIAC ARREST APPROXIMATELY (B)(6) POST INDEX PROCEDURE. NO ADD INFO IS AVAILABLE YET. AT THE TIME OF INDEX PROCEDURE, A 3.0 X 13 MM AND 2.5 X 8 MM CYPHER STENTS WERE BEING PLACED IN THE MLAD AND DCX. THE INVESTIGATOR CONSIDERED THE EVENT WAS NOT RELATED TO THE STUDY DRUG, STENT, OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3367 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death