BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904233 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02432
    Event Type
    Death
    Date Received
    November 12, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 20, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 PATIENT 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. REPORTEDLY, DIRECT STENTING WAS PERFORMED. IT SHOULD BE NOTED THAT THE IFU CAUTIONS THAT THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROXIMATELY 2 YEARS POST DIRECT STENTING OF TWO XIENCE STENTS, ONE IN THE PROXIMAL 1ST OBTUSE MARGINAL ARTERY (P 1STOM), AND ON IN THE MID RIGHT CORONARY ARTERY (MRCA), THE PATIENT DIED. THE PATIENT WAS BEING CONTACTED FOR THEIR 2 YEAR FOLLOW UP. PER A FAMILY MEMBER, THE PATIENT DID IN THEIR SLEEP. CAUSE OF DEATH IS UNK. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL INFORMATION 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 8061161

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death ASPIRIN| SERIAL #(B)(4))| STENT: XIENCE V ((B)(4), LOT #7110561,| OTHER: CLOPIDOGREL,