BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730791 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01200
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    April 2, 2010
    Report Date
    May 24, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESPIRATORY DISTRESS, MENTAL STATUS CHANGE, SEPSIS, DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL, THAT ON (B) (6) 2009, THE PATIENT UNDERWENT STENTING IN THE PREDILATED LEFT DISTAL CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MENTAL STATUS CHANGE AND RESPIRATORY DISTRESS MADE THAT WAS SECONDARY TO A URINARY TRACT INFECTION CAUSING SEPSIS. THE PATIENT'S FAMILY MADE THE PATIENT'S CODE STATUS "DO NOT RESUSCITATE AND DO NOT INTUBATE". THE PATIENT'S RESPIRATORY DISTRESS WAS TREATED WITH A BIPAP MACHINE. THE PATIENT EXPIRED ON (B) (6) 2010, DUE TO RESPIRATORY DISTRESS. 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 9071741

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| H| R