BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER

    MDR report key: 6184854 · Received December 19, 2016

    Report

    Report Number
    2182269-2016-00049
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 24, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD FOR THE ABOVE-REFERENCED PRODUCT WAS UNABLE TO BE REVIEWED SINCE THE BATCH NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ULTIMUM IFU CAUTIONS THAT INSERTION INTO ARTERY MAY CAUSE EXCESSIVE BLEEDING AND/OR OTHER COMPLICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A 27 MM PORTICO VALVE WAS IMPLANTED USING AN ULTIMUM EV HEMOSTASIS INTRODUCER. THE PATIENT DIED FROM HEMORRHAGIC SHOCK AFTER THE TAVI PROCEDURE. PER REPORT, THE SITE STATED THIS WAS POSSIBLY PROCEDURE AND DELIVERY SYSTEM/SHEATH RELATED. THE RELATIONSHIP TO THE VALVE IS UNKNOWN. (CLINICAL STUDY PATIENT (B)(6))

    Description of Event or Problem · 1

    ON (B)(6) 2016, A 27 MM PORTICO VALVE WAS IMPLANTED USING AN ULTIMUM EV HEMOSTASIS INTRODUCER WITH NO COMPLICATIONS. A FEW MINUTES AFTER TRANSFER TO THE ICU, THE PATIENT'S BLOOD PRESSURE DROPPED. REANIMATION MEASURES WERE TAKEN BUT WERE UNSUCCESSFUL. THE PATIENT DIED WITH SUSPECTED HYPOVOLEMIC SHOCK. THE AUTOPSY REPORT RECEIVED 25 JAN 2017 INDICATED THE CAUSE OF DEATH WAS A VASCULAR WALL TEAR AFTER AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838554 ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL C407699

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death