BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1895027 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02353
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INDICATION FOR USE. THE PROMUS STENT INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: ANGINA, ISCHEMIA, AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. REPORTEDLY, THE XIENCE V STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A PROMUS STENT, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES, "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 IFU CAUTIONS, "THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS." IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PT EFFECTS. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PT UNDERWENT STENTING WITH TWO XIENCE V STENTS TO TREAT RESTENOSIS OF A PROMUS STENT IMPLANTED IN THE HEAVILY CALCIFIED LEFT PROXIMAL CIRCUMFLEX ARTERY. ON (B)(6) 2010, THE PROMUS STENT HAD RE-STENOSED AGAIN AND WAS TREATED WITH A DIAGNOSTIC CORONARY ANGIOGRAPHY AND A NON ABBOTT DRUG ELUTING STENT. THE PATIENT'S CONDITION RESOLVED AND WAS DISCHARGED ON (B)(6) 2010. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9072741

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R VESSEL CLOSURE: ANGIO-SEAL| PROMUS STENT| STENT: XIENCE V REF 1009539-08, LOT 9071541