BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12306245 · Received August 11, 2021

    Report

    Report Number
    2916596-2021-04329
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 20, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED EVENTS AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2021, DUE TO ACUTE RIGHT VENTRICULAR FAILURE (RVF). AN AUTOPSY WAS NOT PERFORMED. PER THE IMPLANTING SURGEON, THE EVENT WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE HAD OPERATED AS INTENDED. IT WAS ALSO COMMUNICATED THAT HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6) , WAS NOT EXPLANTED AND WOULD NOT BE RETURNED FOR EVALUATION. THE HEARTMATE 3 LVAS IFU, REV. B IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS 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 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE), STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. ADDITIONALLY, SECTION 6, UNDER ¿CAUTION!¿, EXPLAINS THAT 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. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-023140 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2020. 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PASSED AWAY DUE TO ACUTE RIGHT VENTRICULAR FAILURE. NO AUTOPSY WAS PERFORMED AND THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206412 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 7632547

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death| L