BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1651391 · Received April 2, 2010

    Report

    Report Number
    2024168-2010-00656
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 8, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE XIENCE V 2.5X15 STENT (PART# 1009539-15, LOT# 9071741) INDICATED IS BEING FILED UNDER THE SAME MEDWATCH MFR NUMBER. THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENTS: DEATH, STROKE. TIME OF ADVERSE EVENTS: AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2009, THE PATIENT UNDERWENT STENTING IN THE PREDILATED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH A XIENCE V STENT AND THE PREDILATED PROXIMAL CIRCUMFLEX ARTERY WITH ANOTHER XIENCE V STENT. ON (B) (6) 2010, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR WEAKNESS, NAUSEA, VOMITING, AND UNRESPONSIVENESS. THE PATIENT WAS INTUBATED IN THE EMERGENCY ROOM AND GIVEN INTRAVENOUS SEDATION. THE PATIENT BECAME HYPOTENSIVE AND WAS TREATED WITH A VASOPRESSOR INFUSION. THE PATIENT WAS FOUND TO HAVE UROSEPSIS AND ACUTE RENAL FAILURE. CT SCAN OF THE HEAD ON (B) (6) 2010, SHOWED A LEFT PARIETAL SUBACUTE ISCHEMIC INFARCT. REPEAT CT SHOWED THE SAME INFARCT AND INCREASED CEREBRAL EDEMA. THE PATIENT'S BLOOD PRESSURE CONTINUED TO DECOMPENSATE AND REQUIRED THREE VASOPRESSORS BETWEEN (B) (6) 2010 AND (B) (6) 2010. A BLOOD CULTURE SHOWED THAT THE PATIENT HAD ANAEROBIC GRAM NEGATIVE RODS (BACTERIA) AND WAS TREATED WITH MEDICATION. A CT SCAN OF THE ABDOMEN WAS DONE TO RULE OUT BOWEL ISCHEMIA AS CAUSE OF ANAEROBIC SEPSIS, BUT THE CT SCAN WAS NOT EFFECTIVE FOR THE EVALUATION OF BOWEL ISCHEMIA. THE PATIENT'S DIAGNOSES INCLUDED MULTI-ORGAN FAILURE, SEPTIC SHOCK, ACUTE RENAL FAILURE, AND RESPIRATORY FAILURE. THE PATIENT'S FAMILY DECIDED ON (B) (6) 2010, TO MAKE THE PATIENT A DO NOT RESUSCITATE/DO NOT INTUBATE AND PROVIDE COMFORT CARE ONLY. THE PATIENT DIED SHORTLY AFTER VASOPRESSORS WERE DISCONTINUED ((B) (6) 2010). NO ADDITIONAL INFORMATION WAS 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 9072141

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| R| S XIENCE V 2.5X15 (PART# 1009539-15, LOT# 9071741)| VESSEL CLOSURE: MANUAL COMPRESSION