BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1971358 · Received January 27, 2011

    Report

    Report Number
    3003742446-2011-00039
    Event Type
    Death
    Date Received
    January 27, 2011
    Report Date
    December 30, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A WIFE CALLED ON THE BEHALF OF A PATIENT AND REPORTED AN ADVERSE EVENT. THE PATIENT RECEIVED TWO UNSPECIFIED CORDIS STENTS IMPLANTED IN UNKNOWN VESSELS DUE TO A MILD HEART ATTACK. APPROXIMATELY THREE YEARS AND FIVE MONTHS LATER, THE PATIENT HAD A SEVERE HEART ATTACK WHICH WAS FURTHER DESCRIBED AS THE RESULT OF BAD VALVES. THE PHYSICIAN WAS AWARE. AS TREATMENT, UNSPECIFIED MEDICATIONS WERE PROVIDED AND THE PATIENT WAS DISCHARGED. THE PATIENT EXPIRED DURING THE SAME MONTH AT HOME. NO HOSPITALIZATION OCCURRED. MULTIPLE ATTEMPTS TO RETRIEVE DETAILED INFORMATION ABOUT THE PATIENT AND THE EVENTS WERE UNSUCCESSFUL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MYOCARDIAL INFARCTION AND DEATH ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CYPHER STENT AND THE REPORTED EVENTS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME BECAUSE THERE HAS BEEN NO SPECIFIC ROOT CAUSE IDENTIFIED THAT CAN BE ATTRIBUTED TO EITHER THE PRODUCT DESIGN, RAW MATERIALS USED OR THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DATE OF THE EVENT WAS IN (B)(6) 2009. THE EXACT DATE IS UNKNOWN. PLEASE NOTE THAT THE IMPLANT DATE WAS IN (B)(6) 2005. THE EXACT DATE IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PATIENT HAD TWO UNSPECIFIED CORDIS STENTS IMPLANTED IN UNKNOWN VESSELS DUE TO A MILD HEART ATTACK. ON (B)(6) 2009, THE PATIENT HAD A SEVERE HEART ATTACK WHICH WAS FURTHER DESCRIBED AS THE RESULT OF BAD VALVES. THE PHYSICIAN WAS AWARE. AS TREATMENT, UNSPECIFIED MEDICATIONS WERE PROVIDED. THIS EVENT RESULTED IN DEATH ON (B)(6) 2009 WHILE THE PATIENT WAS HOME, NO HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS OBTAINED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death