BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8617951 · Received May 16, 2019

    Report

    Report Number
    2916596-2019-02202
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 24, 2019
    Report Date
    July 23, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 1 YEAR AND 7 MONTHS. THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. 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) ON (B)(6) 2017. IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH FEELING INCREASINGLY MORE FATIGUED, SHORTNESS OF BREATH, AND DIFFUSELY WEAK ACCOMPANIED BY DARK STOOLS, HOWEVER DENIES BRIGHT BLOOD PER RECTUM. THE PATIENT¿S HEMOGLOBIN (HGB) WAS 6.9 G/DL. ON (B)(6) 2019, THE PATIENT¿S HEMOGLOBIN (HGB) WAS 7.6 G/DL. ON (B)(6) 2019, THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND GIVEN AND A DOSE OF VITAMIN K. AN EGD PERFORMED ON (B)(6) 2019 DEMONSTRATED LOCALIZED FRIABLE MUCOSA NOT AMENDABLE TO ENDOSCOPY THERAPIES. AN AREA IN THE GASTRIC FUNDUS WAS TREATED WITH A CLIP. THE PATIENT WAS DISCHARGED ON (B)(6) 2019 WITH HGB OF 9.0 G/DL AND HAD NO FURTHER BLEEDING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408495 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 5867559

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R