BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2080908 · Received May 7, 2011

    Report

    Report Number
    2024168-2011-03286
    Event Type
    Injury
    Date Received
    May 7, 2011
    Date of Event
    September 8, 2010
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 PATIENT EFFECT OF MYOCARDIAL INFARCTION, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST XIENCE V 3.5 X 28 MM STENT IMPLANTATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY, THE PATIENT EXPERIENCED ELEVATED TROPONIN LEVELS WHICH WAS CLASSIFIED AS A MYOCARDIAL INFARCTION. THERE WAS NO TREATMENT PROVIDED. ON (B)(6) 2010, TWO DAYS AFTER THE PROCEDURE, THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED. 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 908314Q

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability