BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1891216 · Received October 29, 2010

    Report

    Report Number
    2024168-2010-02280
    Event Type
    Death
    Date Received
    October 29, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX 22 MONTHS POST XIENCE V STENT IMPLANTATION ON 2 STENTS IN THE RAMUS ARTERY, THE PT DIED. PER AUTOPSY REPORT, THE CAUSES OF DEATH WERE ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. 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 8041841

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death XIENCE V STENT (B)(4)