BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8404197 · Received March 8, 2019

    Report

    Report Number
    2916596-2019-00940
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 20, 2019
    Report Date
    May 23, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED GI BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, REVIEW OF THE SUBMITTED LOG FILE CONFIRMED ELEVATIONS IN PUMP POWER. THE PATIENT REMAINS ONGOING ON VAD SUPPORT WITH NO FURTHER ISSUES REPORTED. BLEEDING IS LISTED IN THE HEARTMATE II LVAS IFU AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT CARE AND MANAGEMENT SECTION PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE HMII LVAS IFU EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 1 MONTH, 4 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2019 AND WAS FOUND TO HAVE A GI BLEED. THE MANUFACTURER'S TECHNICAL SERVICE REVIEWED THE LOG FILE AND OBSERVED 183 PI EVENTS. ECHOCARDIOGRAM WAS PERFORMED SHOWING RIGHT SIDE IMPAIRMENT WHICH WAS THOUGHT TO BE PATIENT BEING HYPOVOLEMIC. THE PATIENT'S HEMOGLOBIN LEVEL SHOWED 5.4 AND WAS TREATED WITH X4L OF CRYSTALLOIDS AT LEA MEDICAL IN HOBBS, NEW MEXICO. THE PATIENT WAS ALSO TREATED WITH 6 PACKED RED BLOOD CELLS AND MULTIPLE ALBUMIN INFUSION. STOOL GUAIAC TEST WAS PERFORMED AND WAS POSITIVE. ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED ON TWO DAYS AFTER SHOWING MILD GASTRITIS. THE PATIENT BLEEDING WAS STABILIZED AND WAS DISCHARGED WITH HEMOBLOGIN LEVEL OF 10.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196903 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 6559979 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization