BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 7061742 · Received November 27, 2017

    Report

    Report Number
    2916596-2017-02935
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 31, 2017
    Report Date
    February 27, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. A TOTAL OF FOUR UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED OVER THE COURSE OF THE EVENT. THE PATIENT REMAINS ONGOING ON VAD SUPPORT WITH NO FURTHER ISSUES HAVING BEEN REPORTED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REFERENCED PUMP EXCHANGE PROCEDURE WAS REPORTED UNDER MEDWATCH MFR REPORT #2916596-2017-02922 (B)(4). APPROXIMATE AGE OF DEVICE ¿ 1 DAY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT UNDERWENT PUMP EXCHANGE PROCEDURE ON (B)(6) 2017. COMING OUT OF THE OPERATING ROOM THE PATIENT¿S LAB VALUES WERE HEMOGLOBIN AND HEMATOCRIT (H&H) 9.4 G/DL AND 28.7% RESPECTIVELY. THE FOLLOWING MORNING, POST-OP DAY 1, LABORATORY TEST RESULTS SHOWED THE H&H LEVELS HAD DROPPED TO 7.8 G/DL AND 23.8%. THE PATIENT WAS TRANSFUSED 3 UNITS OF PACKED RED BLOOD CELLS (PRBCS) OVER THE COURSE OF THE DAY. ON POST-OP DAY 2, H&H WERE 8.3 G/DL AND 24.7%. PROTHROMBIN TIME (PT) WAS 24.5 SECONDS AND THE INR WAS 1.37. THE PATIENT WAS TRANSFUSED WITH AN ADDITIONAL UNIT OF PRBCS. THE PATIENT WAS NOT ON ANY ANTICOAGULATION. BLEEDING WAS FOUND IN THE GENERAL CHEST AREA, MOSTLY PLEURAL, AND THERE WAS ALSO BLEEDING IN THE PUMP POCKET. THE PATIENT WOULD CONTINUE TO BE FOLLOWED FOR RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837559 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention