BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1891217 · Received October 29, 2010

    Report

    Report Number
    2024168-2010-02284
    Event Type
    Death
    Date Received
    October 29, 2010
    Date of Event
    May 16, 2010
    Report Date
    October 6, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT THROMBOSIS IS A KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION AS RECEIVED: THE DEATH WAS POSSIBLY CAUSED BY LATE STENT THROMBOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROX 6 MONTHS POST DIRECT XIENCE V STENT IMPLANTATION IN THE DISTAL CIRCUMFLEX (DCX) AND THE DISTAL RIGHT CORONARY ARTERY (DRCA), THE PT DIED AT HOME IN BED. REPORTEDLY, PER THE PHYSICIAN, THE DEATH WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE FAMILY HAS NOT PROVIDED ADD'L DETAILS. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT NA 9021241

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death STENT: XIENCE V STENT 1009542-08 LOT 9011261| SERIAL (B)(4) (DISTAL CX)