BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141851 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04517
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 THROMBOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE 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, CANNOT 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 ABOUT 1 1/2 TO 2 HOURS POST-PROCEDURE OF A XIENCE V IMPLANT OF THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, STENT THROMBOSIS OCCURRED. IT WAS NOTED THAT THE PATIENT COMPLAINED OF CHEST PAIN AND THE ANGIOGRAM REVEALED CLOT IN THE STENTED AREA. A NON-ABBOTT ASPIRATION DEVICE WAS USED AND A NON-ABBOTT EXTRACTION DEVICE WAS USED TO REMOVE THE THROMBOSIS. A 4.0 X 15 MM XIENCE STENT WAS PLACED IN THE PROXIMAL AREA OF THE VESSEL BETWEEN A PREVIOUS NON-ABBOTT PROXIMAL, PROXIMAL LAD STENT AND THE MID LAD STENT. THE PATIENT WAS REPORTED AS DOING FINE POST PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 0101241

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention