BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18460269 · Received January 5, 2024

    Report

    Report Number
    2916596-2023-08864
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    September 29, 2023
    Report Date
    February 16, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. SECTION E1: REPORTER ADDRESS LINE 1: (B)(6).

    Additional Manufacturer Narrative · 0

    E1: REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS (LEFT VENTRICULAR ASSIST SYSTEM), SERIAL NUMBER (B)(6), AND THE REPORTED RIGHT HEART FAILURE COULD NOT CONCLUSIVELY BE DETERMINED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS DEVELOPED A RIGHT HEART FAILURE (RHF). THEY WERE ADMITTED TO THE HOSPITAL ON (B)(6) 2023 WITH SYMPTOMS OF ASCITES AND PERIPHERAL EDEMA. THE RELATIONSHIP BETWEEN THE RHF AND THE DEVICE WAS THOUGHT TO BE UNCLEAR. THE PATIENT WAS TREATED WITH DRUG ADJUSTMENT AND WAS DISCHARGED ON (B)(6) 2023.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT ALTHOUGH RIGHT HEART FAILURE EXISTED BEFORE IMPLANT, IT WAS UNKNOWN IF OR HOW DEVICE RELATED ISSUES CONTRIBUTED TO RIGHT HEART FAILURE. THE TREATMENT RESOLVED THE RIGHT HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950586 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8389874 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Hospitalization| R