BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1913208 · Received December 2, 2010

    Report

    Report Number
    2024168-2010-02581
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    June 1, 2009
    Report Date
    November 9, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INDICATION FOR USE: THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU), AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IT WAS REPORTED THAT THE STENTS WERE IMPLANTED IN A VEIN GRAFT. IT SHOULD BE NOTED THAT THE IFU STATES THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IMPLANTED STENT IN THE VEIN GRAFT DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. 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 TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE OTHER XIENCE V (1009545-18, 8052961) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST XIENCE V STENT IMPLANTATION IN A VEIN GRAFT TO THE MID 1ST DIAGONAL (1ST DIAG) AND DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERIES, THE PATIENT EXPERIENCED INCREASED DYSPNEA ON EXERTION AND RECURRENT ANGINA. ON (B)(6) 2009, THE PATIENT HAD AN ABNORMAL STRESS TEST AND ON (B)(6) 2009 A DIAGNOSTIC CATHETERIZATION REVEALED 100% IN-STENT RESTENOSIS (ISR) IN THE 1ST DIAG AND 95% ISR IN THE DLAD. ON (B)(6) 2010 THE ISR WAS TREATED WITH A DRUG ELUTING STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND ON (B)(6) 2010, 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 8052961

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R XIENCE V (1009545-18, 8052961)