BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2013432 · Received March 10, 2011

    Report

    Report Number
    2024168-2011-01549
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 1, 2008
    Report Date
    December 4, 2008
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THROMBOSIS 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, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING OR DESIGN AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FIRST OBTUSE MARGINAL (1OM) ARTERY STENTING PROCEDURE IN A THROMBOSED VESSEL, DURING BALLOON INFLATION TO DEPLOY THE XIENCE V STENT, THROMBUS WAS PUSHED INTO A SIDE BRANCH, RESULTING IN AN OCCLUSION. AFTER STENT PLACEMENT, THE SIDE BRANCH WAS BALLOONED OPEN. A XIENCE V STENT WAS ALSO PLACED IN THE PROXIMAL CIRCUMFLEX (PCX) WITHOUT ISSUE. ONE DAY POST PROCEDURE, THE ASYMPTOMATIC PATIENT EXPERIENCED A NON-CLINICALLY SIGNIFICANT RISE IN THE TROPONIN LEVEL. REPORTEDLY, IT WAS FELT TO BE DUE TO THE PROCEDURE AND WAS NOT DIAGNOSED AS A MYOCARDIAL INFARCTION. ON (B)(6) 2008, 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 8072961

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention ASPIRIN, CLOPIDOGREL