BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1867769 · Received October 7, 2010

    Report

    Report Number
    2024168-2010-02089
    Event Type
    Death
    Date Received
    October 7, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.0 X 28 MM XIENCE V (PART 1009541-28, LOT 0030841) IS BEING FILED UNDER A SEPARATE MFR #. EVALUATION SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. ATRIAL FIBRILLATION/ARRHYTHMIA AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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. IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED TO TREAT A 40 MM LONG LESION. IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES THAT: THIS DEVICE 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 3.75 MM. IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION, TWO XIENCE V STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. POST PROCEDURE, ASPIRIN, CLOPIDOGREL, OLMETEC AND OMEPRAZOLE WERE CONTINUOUSLY ADMINISTERED. THERE WAS NO ANOMALY OBSERVED ON ELECTROCARDIOGRAM AND NO CHEST PAIN. ONE WEEK POST PROCEDURE, THE PATIENT DIED. AUTOPSY WAS NOT PERFORMED; HOWEVER, PER PHYSICIAN, THE CAUSE OF DEATH IS ATRIAL FIBRILLATION. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 0051041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death LOT 0030841)| DILATATION CATHETER 2.75 X 15 MM HIRYU| STENT: 3.0 X 28 MM XIENCE V (PART 1009541-28,