BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1680715 · Received May 10, 2010

    Report

    Report Number
    2024168-2010-00948
    Event Type
    Death
    Date Received
    May 10, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 15, 2010
    Manufacturer
    ABBOT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MFR, DESIGN OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2010, THE PT UNDERWENT STENTING IN THE PREDILATED MID RIGHT CORONARY ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2010, THE PT DIED OF AN UNKNOWN CAUSE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOT VASCULAR CLONMEL NA 9110542

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death VESSEL CLOSURE: ANDIO-SEAL