BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1747758 · Received July 1, 2010

    Report

    Report Number
    2024168-2010-01310
    Event Type
    Death
    Date Received
    July 1, 2010
    Date of Event
    January 13, 2010
    Report Date
    June 9, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE STENTS REMAIN IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 3.0 X 23 MM XIENCE V (PART 1009541-23, LOT 9070961) 3.5 X 15 MM XIENCE V (PART 1009542-15, LOT 9081241 AND THE 3.5 X 12 MM XIENCE V (PART 1009542-12, LOT 8103163), ARE BEING FILED UNDER THIS MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNEVENTFUL STENTING IN THE PREDILATED SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL WITH TWO XIENCE V STENTS AND IN THE PREDILATED MID RIGHT CORONARY ARTERY WITH TWO XIENCE V STENTS. THESE STENTS WERE NOT OVERLAPPING. ON (B)(6) 2009, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH WORSENING COUGH, SHORTNESS OF BREATH, AND FEVER. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA, CONGESTIVE HEART FAILURE AND DURING THE HOSPITAL STAY DEVELOPED ACUTE RESPIRATORY DISTRESS SYNDROME AND A BLEEDING DISORDER. THE PATIENT WAS INTUBATED FOR MECHANICAL VENTILATION, BUT THE PATIENT'S CONDITION CONTINUED TO DECLINE. THE PATIENT WAS FOUND TO HAVE AN ELEVATED CK AND MB BAND, BUT THERE WAS NO REPORTED INTERVENTION FOR THE ELEVATED ENZYMES. THE PATIENT'S ECG ON ADMISSION SHOWED A NORMAL SINUS RHYTHM. THE PATIENT EXPIRED ON (B)(6) 2010, IN THE HOSPITAL. 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 78 YR Death| H LOT 9070961)| STENT: 3.0 X 23 MM XIENCE V (PART 1009541-23| 3.5 X 15 MM XIENCE V (PART 1009542-15, LOT 9081241| GUIDE WIRE: PROWATER| 3.5 X 12 MM XIENCE V (PART 1009542-12, LOT 8103163