BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2230889 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06070
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH AND MYOCARDIAL INFARCTION (MI) ARE LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 45 MONTHS AFTER THE XIENCE V STENT IMPLANTATION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION, SEVERE HYPOXIC ENCEPHALOPATHY, AND SUBSEQUENT CARDIOPULMONARY ARREST AND DEATH DESPITE TREATMENT WITH MEDICATION. THIS EVENT WAS REPORTEDLY UNRELATED TO THE STENTING PROCEDURE OR DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 70228P5

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death