BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141869 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04519
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 22, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 ANGINA, RE-STENOSIS, AND MI, ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS 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. THE 3.0 X 23 MM XIENCE V IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT STENTING IN THE LEFT MAIN CORONARY ARTERY WITH THE 3.0X23 XIENCE V STENT AND IN THE LEFT CIRCUMFLEX ARTERY WITH THE 3.0X28 XIENCE V STENT. ON (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN AND DYSPNEA. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA. THE PATIENT WAS FOUND TO HAVE ELEVATED TROPONIN AND WAS DIAGNOSED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION (MI). ON (B)(6) 2011, THE PATIENT HAD A CORONARY ANGIOGRAM AND WAS FOUND TO HAVE IN-STENT RESTENOSIS IN BOTH INDEX XIENCE STENTS. ONE 3.5X23 XIENCE V STENT WAS IMPLANTED TO COVER ALL AREAS OF THE RESTENOSIS. THE PATIENT'S CONDITION IMPROVED. 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 0021641

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R STENT: XIENCE V 3.0 X 23 MM