BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4770080 · Received May 13, 2015

    Report

    Report Number
    2024168-2015-02695
    Event Type
    Death
    Date Received
    May 13, 2015
    Date of Event
    September 1, 2014
    Report Date
    April 29, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MYOCARDIAL INFARCTION AND DEATH ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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 ON (B)(6) 2013, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE WITH PLACEMENT OF A 2.25 X 18 MM XIENCE PRIME STENT IN THE PROXIMAL CIRCUMFLEX ARTERY. IN (B)(6)2014, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312076 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3012341

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death ASPIRIN, CLOPIDOGREL