BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1887560 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02244
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 31, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V (P.N. 1009543-18, LOT#9080661) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. (B)(4). (USE IN RESTENOSED LESION). EVAL SUMMARY: THE REPORTED PT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V STENT DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS. IT WAS REPORTED THAT TWO OF THE XIENCE V STENTS WERE USED TO TREAT A RESTENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND A RESTENOSED LEFT MAIN CORONARY ARTERY TO THE LEFT CIRCUMFLEX. PER THE XIENCE V IFU, THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH GREATER THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE REPORTED TREATMENT OF THE RESTENOSED LESIONS DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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 MFR, DESIGN, AND LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY SIX MONTHS AFTER THE IMPLANTATION OF ONE XIENCE V STENT IN THE PREDILATED, RESTENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE IMPLANTATION OF ONE XIENCE V STENT IN THE PREDILATED, RESTENOSED LEFT MAIN CORONARY ARTERY TO THE LEFT CIRCUMFLEX, THE PT EXPERIENCED AN ACUTE CORONARY SYNDROME. THE PT HAD A DIAGNOSTIC CORONARY ANGIOGRAM THAT FOUND IN-STENT RESTENOSIS IN THE LAD. THE PT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE LEFT CIRCUMFLEX ARTERY IN-STENT RESTENOSIS WITH A NON-ABBOTT STENT, BUT THE LAD WAS NOT TREATED AT THAT TIME. THE PT WAS DISCHARGED FOUR DAYS AFTER REVASCULARIZATION. THERE WAS NO ADDITIONAL INFO 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 9092961

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| S VESSEL CLOSURE: ANGIO-SEAL| STENT: XIENCE V (P.N. 1009543-18, LOT# 9080661)