BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14777617 · Received June 22, 2022

    Report

    Report Number
    2916596-2022-11695
    Event Type
    Death
    Date Received
    June 22, 2022
    Date of Event
    November 18, 2021
    Report Date
    June 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMAITON HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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 EVENTS (RIGHT HEART FAILURE, INFECTION, SEPSIS, AND PATIENT EXPIRATION) CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT WAS IMPLANTED WITH HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), ON (B)(6) 2018. ON (B)(6) 2021 THE PATIENT EXPIRED DUE TO RIGHT HEART FAILURE AND SEPTIC SHOCK STEMMING FROM A PERITONEAL INFECTION. THE PATIENT HAD A PRE-EXISTING HISTORY OF HEART FAILURE, AND THE PATIENT OUTCOME WAS NOT CONSIDERED TO BE DEVICE RELATED. HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), WAS REPORTED TO HAVE BEEN OPERATING AS INTENDED AND WILL NOT BE RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. REVIEW OF THE STERILIZATION AND PACKAGING DOCUMENTATION SHOWED NO DEVIATION FROM MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C, CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS SEPSIS, INFECTION, RIGHT HEART FAILURE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6 LISTS INFECTION AS A POTENTIAL LATE POST-IMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO 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 LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP." CARE INSTRUCTIONS REGARDING PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THIS DOCUMENT. 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 PASSED AWAY DUE TO RIGHT SIDED HEART FAILURE AND SEPTIC SHOCK. THE SEPTIC SHOCK WAS CAUSED BY A PERITONEAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241256 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 6372136 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death