BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1373073 · Received April 30, 2009

    Report

    Report Number
    2024168-2009-00739
    Event Type
    Injury
    Date Received
    April 30, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 6, 2009
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V (LOT# 8082761) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. ANGINA AND RESTENOSIS ARE KNOWN RISKS OF STENTING AND ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EVENTS. THESE PATIENT EFFECTS ALONG WITH FATIGUE AND HOSPITALIZATION, ARE LISTED IN THE RISK ASSESSMENT AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. FATIGUE CAN BE ASSOCIATED WITH MANY OTHER THINGS BESIDES THE STENTS, SUCH AS THE OVERALL HEALTH AND CONDITION OF THE PATIENT OR MEDICATIONS. ANGINA AND FATIGUE MAY HAVE BEEN SECONDARY EFFECTS OF THE RESTENOSIS. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY- MEDICATION INTERVENTION; PERMANENT DAMAGE. REPORTING RATIONALE: IN-STENT RESTENOSIS REQUIRING MEDICAL INTERVENTION VIA CORONARY ARTERY BYPASS GRAFT CAUSING PERMANENT IMPAIRMENT. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRAIL THAT AFTER THE 2.5 X 28 MM AND 4.0 X 18 MM XIENCE V STENTS WERE IMPLANTED, THE PATIENT EXPERIENCED FATIGUE AND VAGUE CHEST PAIN (ANGINA) ONSET (ACTUAL DATE IS UNKNOWN). THERE WAS IN-STENT RESTENOSIS WHICH WAS TREATED WITH A CORONARY ARTERY BYPASS GRAFT (CABG), REQUIRING HOSPITALIZATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    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 8061261

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R| S XIENCE V (LOT# 8082761)