BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1743114 · Received June 29, 2010

    Report

    Report Number
    2024168-2010-01283
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    February 2, 2010
    Report Date
    June 4, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4): THE 3.5 X 18 MM XIENCE V (PART 1009542-18, LOT 7082061), INDICATED IS BEING FILED UNDER THIS MFR#. EVAL SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT 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. SINCE IT WAS REPORTED THAT THE ANTIPLATELET MEDICATION WAS DISCONTINUED AND WAS CHANGED TO ASPIRIN, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: THE XIENCE V STENT IS CONTRAINDICATED FOR USE IN PTS WHO CANNOT RECEIVE ANTIPLATELET AND/OR ANTI-COAGULANT THERAPY. ADDITIONALLY, THE IFU STATES: ANTIPLATELET DRUGS SHOULD BE USED IN COMBINATION WITH THE XIENCE V STENT. THE IFU NOTES THAT: IT IS VERY IMPORTANT THAT THE PT IS COMPLIANT WITH THE POST-PROCEDURAL ANTIPLATELET THERAPY RECOMMENDATIONS. EARLY DISCONTINUATION OF PRESCRIBED ANTIPLATELET MEDICATION COULD RESULT IN A HIGHER RISK OF THROMBOSIS, MYOCARDIAL INFARCTION (MI), OR DEATH. PTS WHO REQUIRE EARLY DISCONTINUATION OF ANTIPLATELET THERAPY (E.G., SECONDARY TO ACTIVE BLEEDING) SHOULD BE MONITORED CAREFULLY FOR CARDIAC EVENTS.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: APPROX 21 MONTHS AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT APPROX 1 MONTH POST A RIGHT CORONARY ARTERY STENTING PROCEDURE, WITH TWO XIENCE V STENTS THE PT EXPERIENCED A GASTRO-INTESTINAL (GI) BLEED. ANTIPLATELET MEDICATION WAS DISCONTINUED AND THE PT WAS CHANGED TO ASPIRIN. APPROX 21 MONTHS AFTER THE PROCEDURE, THE PT WAS HOSPITALIZED. CARDIAC ENZYMES WERE NEGATIVE AS WAS THE ECG FOR MYOCARDIAL INFARCTION. ON 02/24/2010, THE PATIENT DIED. CAUSE OF DEATH IS LISTED AS MULTISYSTEM FAILURE OF UNK SOURCE. ALTHOUGH REQUESTED, THERE WAS NO ADD'L 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 7102442

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H VESSEL CLOSURE: ANGIO-SEAL| (PART 1009542-18, LOT 7082061)| STENT: 3.5X18MM XIENCE V