BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22479848 · Received July 11, 2025

    Report

    Report Number
    2916596-2025-04420
    Event Type
    Death
    Date Received
    July 11, 2025
    Date of Event
    January 1, 2020
    Report Date
    July 23, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2020 AS DATA WAS COLLECTED BETWEEN 2018 AND 2020. ARTICLE INFORMATION: LERMAN, J. B., CYR, D. D., CHISWELL, K., TOBIN, R. S., FUDIM, M., POKORNEY, S. D., MENTZ, R. J., & SAMSKY, M. D. (2023). THE USE OF THE MULTISENSOR HEARTLOGIC ALGORITHM FOR HEART FAILURE REMOTE MONITORING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES. ASAIO JOURNAL (AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS : 1992), 69(7), E351¿E353. HTTPS://DOI.ORG/10.1097/MAT.0000000000001946. DUKE UNIVERSITY SCHOOL OF MEDICINE, DURHAM, NORTH CAROLINA. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION WITH THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO HEARTMATE 3 LVAD¿S WERE RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED DUE TO THE SERIAL NUMBER OF THE LVAD BEING UNKNOWN. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿THE USE OF THE MULTISENSOR HEARTLOGIC ALGORITHM FOR HEART FAILURE REMOTE MONITORING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH ARRHYTHMIA, GASTROINTESTINAL BLEEDING, HYPOVOLEMIA, PAIN, ORTHOSTASIS, DEATH, HEART FAILURE, AND HOSPITALIZATION. THIS MULTICENTER RETROSPECTIVE STUDY EVALUATED 14 PATIENTS EQUIPPED WITH A HEARTLOGIC CAPABLE DEVICE WHO WERE IMPLANTED BETWEEN 2018 AND 2020. THE STUDY¿S OBJECTIVE WAS TO CHARACTERIZE THE USE OF HEARTLOGIC MONITORING AMONG PATIENTS IMPLANTED WITH A DURABLE LEFT VENTRICULAR ASSIST DEVICE. THE STUDY MONITORED THE REASONS FOR HOSPITALIZATIONS AND DIVIDED THEM INTO 2 GROUPS, HEART FAILURE (HF) RELATED HOSPITALIZATIONS AND NON-HF RELATED HOSPITALIZATIONS. THE SITE DEFINED HF RELATED HOSPITALIZATIONS AS PATIENTS REPORTING AT LEAST ONE SYMPTOM OF HF, DEMONSTRATING AT LEAST ONE OBJECTIVE SIGN OF DECOMPENSATED HF (IMAGING, BIOMARKER, PHYSICAL EXAMINATION, OR HEMODYNAMIC EVIDENCE OF CONGESTION), AND HAD RECEIVED AN ESCALATION IN DIURETIC THERAPY WITHIN 48 HOURS OF ADMISSION. THERE WERE 29 HOSPITALIZATIONS OVER THE STUDY PERIOD, OF WHICH 10 WERE HF RELATED HOSPITALIZATIONS, AND 19 WERE NON-HF RELATED HOSPITALIZATIONS. 7 PATIENTS EXPERIENCED ARRHYTHMIA, 5 PATIENTS EXPERIENCED AN INFECTION, 2 PATIENTS EXPERIENCED GASTROINTESTINAL BLEEDING, 2 PATIENTS EXPERIENCING HYPOVOLEMIA, 2 PATIENTS EXPERIENCED PAIN, AND 1 PATIENT EXPERIENCED ORTHOSTASIS. 3 PATIENTS PASSED AWAY. IN CONCLUSION, THE STUDY FOUND THAT HEARTLOGIC MAY HOLD PROMISE FOR PREDICTION OF NON-HF ASSOCIATED HOSPITALIZATIONS, WITH LESS CERTAINTY REGARDING HF-ASSOCIATED HOSPITALIZATIONS, IN LVAD PATIENTS. FURTHER INVESTIGATION WAS NOTED TO BE WARRANTED IN LARGER, PROSPECTIVE COHORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873674 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death