BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11903068 · Received May 28, 2021

    Report

    Report Number
    2916596-2021-02583
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    November 9, 2020
    Report Date
    July 22, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED RIGHT HEART FAILURE (RHF) COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT LATER COMMUNICATED THAT BETA BLOCKERS (BB) WERE HELD DUE TO THE SEVERE RIGHT VENTRICULAR (RV) DYSFUNCTION FOUND VIA ECHO ON (B)(6) 2020. THE PATIENT WAS LATER ADMITTED FOR RV FAILURE (MFR # 2916596-2021-02353). THE ACCOUNT COMMUNICATED THAT THE PATIENT WAS DOING WELL AS AN OUTPATIENT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT ALSO DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. THE IFU FURTHER EXPLAINS THAT RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 06APR2020. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 HAD RIGHT HEART FAILURE. AN ECHOCARDIOGRAM ON (B)(6) 2020 OF THE RIGHT VENTRICLE READ AS MODERATELY DILATED WITH MODERATELY DEPRESSED FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800521 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7412381 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization