BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 17952686 · Received October 17, 2023

    Report

    Report Number
    2916596-2023-07260
    Event Type
    Death
    Date Received
    October 17, 2023
    Date of Event
    September 10, 2023
    Report Date
    May 31, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    RIGHT HEART FAILURE HAS PREVIOUSLY BEEN REPORTED FOR THIS PATIENT UNDER MFR #: 2916596-2022-14279. 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, CARDIAC ARREST, AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND DEATH, 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. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D1 BRAND NAME: CORRECTED. SECTION D4 CATALOG NUMBER: CORRECTED. SECTION D4 PRIMARY UDI NUMBER: CORRECTED. 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 EXPERIENCED SYMPTOMS OF VOLUME OVERLOAD THOUGHT TO BE DUE TO RIGHT HEART FAILURE. THIS WAS TREATED WITH DOBUTAMINE. THEY PASSED AWAY DUE TO CARDIAC ARREST AND RIGHT HEART FAILURE.

    Description of Event or Problem · 0

    IT WAS UNKNOWN IF THE PATIENT'S RIGHT HEART FAILURE EXISTED PRIOR TO THE LEFT VENTRICULAR ASSIST DEVICE IMPLANT; HOWEVER, IT WAS COMMUNICATED THAT THERE WERE NO DEVICE-RELATED ISSUES THAT CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT¿S OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY-RELATED AND THE DEVICE HAD REPORTEDLY OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077715 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8136815

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death