BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2083158 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03343
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 RESTENOSIS IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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. DATE OF OCCURRENCE ESTIMATED AS (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST IMPLANTATION OF 3 XIENCE V STENTS IN THE FIRST OBTUSE MARGINAL (1ST OM), THE PATIENT EXPERIENCED SHORTNESS OF BREATH WITH EXERTION. ON (B)(6) 2011, A NUCLEAR STRESS TEST WAS ABNORMAL. ON (B)(6) 2011, 100% IN-STENT RESTENOSIS OF THE 1ST OM WAS NOTED AND THE STENOSIS WAS TREATED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. ALTHOUGH REQUESTED, 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 8041841

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R