BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1059190 · Received June 10, 2008

    Report

    Report Number
    3003742446-2008-00103
    Event Type
    Death
    Date Received
    June 10, 2008
    Date of Event
    March 10, 2008
    Report Date
    February 5, 2007
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PT'S WIFE CALLED TO REPORT THAT HER HUSBAND HAD DIED OF A MYOCARDIAL INFARCTION AFTER HAVING CORONARY STENTS IMPLANTED. THE PT'S HISTORY IS SIGNIFICANT FOR OBESITY, DIABETES, HYPERLIPIDEMIA, HYPERTENSION AND CAROTID ENDARTERECTOMY. THE INDICATION FOR THE PROCEDURE WAS A POSITIVE CARDIAC CATHETERIZATION CONFIRMING FOUR-VESSEL DISEASE. TWO CYPHER STENTS WERE IMPLANTED IN THE LAD, THE PT NEEDED TWO MORE STENTS BUT THE LOCATION OF THE LESIONS WOULD NOT ALLOW FOR STENT PLACEMENT SO THE LESIONS WERE LEFT UNTREATED. APPROX FOUR YRS LATER THE PT EXPERIENCED A MASSIVE MYOCARDIAL INFARCTION, REQUIRING THE PT BE PLACED ON LIFE SUPPORT. EEG REVEALED A PERSISTENT VEGETATIVE STATE AND AN ECHOCARDIOGRAM REVEALED THAT THE PT'S HEART WAS THREE TIMES NORMAL SIZE. THE PT WAS TAKEN OFF LIFE SUPPORT AFTER A WEEK AND EXPIRED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN. MYOCARDIAL INFARCTION AFTER HAVING CORONARY STENTS IMPLANTED IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PROCEDURE. IT IS ALSO NORMAL PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE INFO REPORT REGARDING THE PT'S MEDICAL HISTORY AND THE LESIONS THAT WERE LEFT UNTREATED, THERE ARE POSSIBLE PT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MFG REPORT #S: 3003742446-2008-00103 AND 3003742446-2008-00104.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT. NOTIFICATION WAS REC'D FROM THE CORDIS MEDICAL AFFAIRS OFFICE INDICATING THE PT'S WIFE HAD CALLED TO REPORT HIS DEATH. IN 2008, THE PT EXPERIENCED A MASSIVE MYOCARDIAL INFARCTION. HE WAS PLACED ON LIFE SUPPORT AND WAS FOUND TO BE IN A PERSISTENT VEGETATIVE COMA ACCORDING TO EEG EXAM. ECHOCARDIOGRAM EXAM OF THE HEART REVEALED THE HEART WAS THREE TIMES NORMAL SIZE. AT APPROXIMATELY 7 DAYS LATER, THE PT WAS TAKEN OFF OF LIFE SUPPORT AND EXPIRED. AN AUTOPSY WAS NOT PERFORMED. AT THE TIME OF THIS REPORT, NO FURTHER INFO WAS KNOWN. THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 40304288

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death