BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 20987380 · Received December 20, 2024

    Report

    Report Number
    2916596-2024-52809
    Event Type
    Death
    Date Received
    December 20, 2024
    Date of Event
    December 13, 2024
    Report Date
    March 6, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 PATIENT OUTCOME DUE TO RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS WILL REPORTEDLY NOT BE EXPLANTED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO RELEVANT DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A4 PATIENT WEIGHT NOT PROVIDED. B5: ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE RHF REPORTEDLY DID NOT EXIST PRE-LVAD IMPLANT. A DEVICE ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE RIGHT HEART FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE (RHF) THE SAME DAY OF LVAD IMPLANTATION. THE OUTCOME WAS NOT DEVICE RELATED. IT WAS STATED THAT THE PATIENT HAD PASSED AWAY DUE TO RHF DESPITE HIGH DOSAGE OF INOTROPIC SUPPORT GIVEN AT THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2024. CAUSE OF DEATH REPORTEDLY DID NOT RELATE WITH FUNCTIONALITY OF LVAD. THE PUMP WORKED AS INTENDED. AN AUTOPSY WAS NOT PERFORMED AND WOULD NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164135 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT L00000567

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death