BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1696178 · Received May 20, 2010

    Report

    Report Number
    2024168-2010-01012
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    February 15, 2010
    Report Date
    April 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. CEREBROVASCULAR ACCIDENT/STROKE, DEATH, INFECTION, AND RENAL FAILURE ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 THE MANUFACTURE OR DESIGN. THE SECOND 3.0X18 XIENCE V RX (PART 1009541-18, LOT UNK), INDICATED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. THE XACT STENT WAS FILED UNDER MFR # 2004742046-2010-00090.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: STROKE EVOLUTION/DEATH. TIME OF ADVERSE EVENT: EIGHTEEN DAYS POST PROCEDURE. IT WAS REPORTED THAT ON (B) (6) 2010, TWO XIENCE V STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. POST PROCEDURE, THE PATIENT DEVELOPED ACUTE CORONARY HEART FAILURE (CHF) WITH ELEVATED TROPONIN LEVELS. ADDITIONALLY, THE PATIENT DEVELOPED A LARGE RIGHT CEREBELLAR INFARCTION. ON (B) (6) 2010, AN XACT STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY. ON (B) (6) 2010, NEUROLOGY CONSULT REPORTS VACILLATING MENTAL STATUS DUE TO METABOLIC ENCEPHALOPATHY FROM CHF, PNEUMONIA, DECREASED RENAL FUNCTION AND WORSENING O2 SATS. THE PATIENT WAS DEEMED "DO NOT RESUSCITATE" AND EXPIRED LATER THAT EVENING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death DIL CATH: 2.75X6 VOYAGER NC RX| EMBOLIC PROTECTION: EMBOSHIELD NAV 6| OTHER: HEPARIN| 2.5X12 VOYAGER RX| XACT (PART 82096-01, LOT 9103051)| STENT: 3.0X18 XIENCE V RX(PART 1009541-18,LOT UNK)