BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2162721 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04965
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    October 14, 2010
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 AND STENOSIS 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 EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER 3 YEARS POST XIENCE V STENT IMPLANTATION IN THE 1ST OBTUSE MARGINAL ARTERY, THE PATIENT EXPERIENCED ANGINA. REPORTEDLY, THERE WAS NEW BLOCKAGE IN THE VESSEL THAT DID NOT INVOLVE THE INDEX STENT. THE PATIENT WAS HOSPITALIZED AND TREATED WITH MEDICATION. ON (B)(6) 2010, A XIENCE V STENT WAS PLACED IN THE TARGET VESSEL. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ON (B)(6) 2011, AN ANGIOGRAM WAS DONE SHOWING ALL STENTS WERE WIDELY PATENT. 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 60609P1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R