BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10041893 · Received May 11, 2020

    Report

    Report Number
    2916596-2020-02299
    Event Type
    Death
    Date Received
    May 11, 2020
    Date of Event
    April 23, 2020
    Report Date
    June 1, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED VENTRICULAR TACHYCARDIA, RIGHT HEART FAILURE, AND PATIENT OUTCOME COULD NOT BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT WAS READMITTED WITH SEVERE VENTRICULAR TACHYCARDIA (VT) ON (B)(6) 2020. THE CAUSE OF THE VT REPORTEDLY REMAINED UNKNOWN. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2020 DUE TO VT AND RIGHT HEART FAILURE. THE OUTCOME WAS REPORTEDLY NOT DEVICE OR DEVICE THERAPY RELATED AND THE PUMP FUNCTIONED AS EXPECTED WITHOUT ISSUE. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED AND IS NOT AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 04AUG2017 VIA CUSTOMER ORDER S188140. THE HEARTMATE 3 LVAS IFU LISTS CARDIAC ARRHYTHMIA, RIGHT HEART FAILURE, AND DEATH AS ADVERSE EVENTS 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. SECTION 6 (UNDER CAUTION!) STATES THAT 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 LEFT VENTRICULAR ASSIST SYSTEM 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

    THE PATIENT WAS READMITTED FOR SEVERE VENTRICULAR TACHYCARDIA (VT) ON (B)(6) 2020 AND SUBSEQUENTLY EXPIRED DUE TO VT AND RIGHT HEART FAILURE ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505788 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6087883

    Patients

    Seq Age Sex Outcome Treatment
    1 Death