BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1635308 · Received March 18, 2010

    Report

    Report Number
    2024168-2010-00510
    Event Type
    Death
    Date Received
    March 18, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 23, 2010
    Manufacturer
    ABBOTT VASCULAR- CLONMEL
    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). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO THE MANUFACTURING, DESIGN OR LABELING. THE 2.5 X 15 MM XIENCE V (PART 1009539-15, LOT 7110141), AND THE 2.5 X 23 MM XIENCE V (PART 1009539-23, LOT 7102981), INDICATED ARE BEING FILED UNDER THIS MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: POST PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2008, THE PT UNDERWENT STENTING OF THE PRE-DILATED MID LEFT ANTERIOR DESCENDING ARTERY WITH THREE XIENCE V STENTS. ON (B) (6) 2010, THE PT WAS ADMITTED TO HOSPICE AT HOME WITH DIAGNOSIS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PT EXPIRED ON (B) (6) 2010. DEATH CERTIFICATE READS THAT CAUSE OF DEATH WAS DUE TO EXACERBATION OF COPD. THOUGH REQUESTED, 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- CLONMEL NA 7102241

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death STENT: 2.5 X 15 MM XIENCE V| (PART 1009539-15, LOT 7110141)| 2.5 X 23 MM XIENCE V| (PART 1009539-23, LOT 7102981)