BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020806 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01777
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 5, 2008
    Report Date
    March 13, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. MYOCARDIAL INFARCTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT POST IMPLANTATION OF 3 XIENCE V STENTS IN THE SECOND OBTUSE MARGINAL, PROXIMAL CIRCUMFLEX ARTERY AND THE PROXIMAL FIRST DIAGONAL ARTERY, THE PATIENT EXPERIENCED ELEVATED TROPONIN, WHICH WAS DIAGNOSED AS A PERIPROCEDURE NON ST ELEVATION MYOCARDIAL INFARCTION. THE CONDITION RESOLVED ON (B)(6) 2008 AND THE PATIENT WAS DISCHARGED TO HOME. THERE WAS NO ADDITIONAL INFORMATION 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 8060661

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| S XIENCE V 2.5X12MM, 2.5X8MM