BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4121250 · Received September 23, 2014

    Report

    Report Number
    2916596-2014-01590
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED GI BLEED COULD NOT BE DETERMINED. THE PATIENT WAS TREATED AND THE BLEEDING ISSUES WERE RESOLVED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT WITH NO FURTHER EVENTS REPORTED TO THE MANUFACTURER. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE PUMP. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 3 MONTHS POST-IMPLANT IT WAS REPORTED THAT THE PT WAS READMITTED INTO THE HOSPITAL DUE TO GI BLEEDING. THE PT RECEIVED 8 UNITS OF PACKED RED BLOOD CELLS AND WAS RESTARTED ON WARFARIN. A COLONOSCOPY INDICATED A RECTAL POLYP WHICH WAS NOT REMOVED AND A GASTROSCOPY INDICATED A MEDIUM SIZE HIATUS HERNIA. IN ADDITION THE PT RECEIVED A PILL CAM TEST AND THE RESULTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591214 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 129243

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention