BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1594702 · Received February 3, 2010

    Report

    Report Number
    2024168-2010-00175
    Event Type
    Death
    Date Received
    February 3, 2010
    Date of Event
    November 1, 2009
    Report Date
    January 11, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE TWO ADD'L RX XIENCE V 2.5 X 12 M (PART# 1009539-12/LOT# 8091261) AND 4.0 X 18MM (PART# 1009543-18/LOT# 8081961) MENTIONED ARE BEING FILED UNDER THE SAME MFR NUMBER. THE REPORTED PT EFFECTS ARE KNOWN ADVERSE EVENTS LISTED IN THE RISK ASSESSMENT. A CONCLUSIVE CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE XIENCE V IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. IT IS UNK HOW THIS MAY HAVE CONTRIBUTED TO THE REPORTED PT'S EFFECT.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THREE DE NOVO LESIONS WERE TREATED DURING THE INDEX PROCEDURE, AN ARTERIAL GRAFT, 1ST OBTUSE MARGINAL, AND THE LEFT ARTERY. NO PRE-DILATION WAS PERFORMED PRIOR TO STENTING OF THE ARTERIAL GRAFT WITH ONE XIENCE V STENT. PRE-DILATATION WAS PERFORMED PRIOR TO STENTING OF THE FIRST OBTUSE MARGINAL AND THE LEFT MAIN WITH ONE XIENCE V STENT IN EACH VESSEL. NO PROCEDURAL COMPLICATIONS WERE REPORTED. ON (B) (6) 2009, THE PT EXPIRED. THE PT WAS UNDER HOSPICE CARE FOR END STAGE CONGESTIVE HEART FAILURE. THE DEATH CERTIFICATE READS CORONARY DISEASE, CONGESTIVE HEART FAILURE, PULMONARY FIBROSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION AND CHRONIC KIDNEY DISEASE AS THE CAUSE OF DEATH. THERE IS NO ADD'L INFO 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 8053041

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death (PART# 1009539-12/LOT# 8091261)| RX XIENCE V 2.5X12M| RX XIENCE V 4.0 X 18MM| (PART# 1009543-18/LOT# 8081961)