BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1638601 · Received March 22, 2010

    Report

    Report Number
    2024168-2010-00547
    Event Type
    Death
    Date Received
    March 22, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 26, 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
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. RESPIRATORY FAILURE/ARREST AND DEATH ARE RECOGNIZED AS NO FAULT COMPLICATIONS IN THE NO FAULT RISK ASSESSMENT. DEATH IS ALSO LISTED AS KNOWN ADVERSE EVENTS OF CORONARY STENTING IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). SINCE RESPIRATORY FAILURE IS NOT SPECIFICALLY LISTED AS A KNOWN ADVERSE EVENT OF CORONARY STENTING IN THE IFU, THERE IS A NEED TO EVALUATE THIS IFU DOCUMENTATION FOR A POTENTIAL UPDATE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: TWO DAYS POST PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO GENERALIZED WEAKNESS AND SHORTNESS OF BREATH. THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED, FUNCTIONAL ISCHEMIA STUDY WAS POSITIVE; A NON-ST-ELEVATION NON Q-WAVE MYOCARDIAL INFARCTION WAS DIAGNOSED. MEDICATION WAS ADMINISTERED. DIAGNOSTIC CORONARY ANGIOGRAPHY WAS PERFORMED - RESULTS NOT REPORTED. ON (B) (6) 2010, THE PATIENT UNDERWENT STENTING OF THE PRE-DILATED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 3.0 X 12 XIENCE V STENT. ON (B) (6) 2010, THE PATIENT EXPERIENCED INCREASED SHORTNESS OF BREATH, NON-PRODUCTIVE COUGH, TACHYPENIA AND LETHARGY. THE PATIENT WAS DIAGNOSED WITH ACUTE ONSET OF RESPIRATORY FAILURE DUE TO ADVANCED CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PATIENT WAS PLACED ON A BI-LEVEL POSITIVE AIRWAY PRESSURE MACHINE. THE PATIENT REQUESTED A DNR AND INTUBATION WAS DECLINED. THE PATIENT EXPIRED ON (B) (6) 2010. NO DEATH REPORT OR CAUSE OF DEATH WAS RECEIVED. THOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    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 9092861

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death