BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24927321 · Received April 20, 2026

    Report

    Report Number
    2916596-2026-02292
    Event Type
    Death
    Date Received
    April 20, 2026
    Date of Event
    January 1, 2017
    Report Date
    April 20, 2026
    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. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2017 AS THE DATE OF DATA COLLECTION WAS BETWEEN 2017 AND 2023. CHAUDHARY, A., O¿CONNOR, M., EDELSON, J., ROSSANO, J., LORTS, A., ROSENTHAL, D., SHEZAD, M., WRIGHT, L., MAEDA, K., PLUYM, C. V., & AHMED, H. (2025). EVALUATION OF GENDER DISPARITIES AMONG PEDIATRIC PATIENTS WITH THE HEARTMATE 3 VENTRICULAR ASSIST DEVICE. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.169 CHILDREN'S HOSPITAL OF PHILADELPHIA, PHILADELPHIA, PA MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. 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 TITLED ¿EVALUATION OF GENDER DISPARITIES AMONG PEDIATRIC PATIENTS WITH THE HEARTMATE 3 VENTRICULAR ASSIST DEVICE¿ THAT HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE ASSOCIATED WITH DEATH. THIS STUDY EVALUATED POTENTIAL GENDER DIFFERENCES IN HM3 LVAD IMPLANTATION AND OUTCOMES IN PEDIATRIC PATIENTS, ADDRESSING A GAP PREVIOUSLY IDENTIFIED IN ADULT POPULATIONS. USING THE ACTION REGISTRY, INVESTIGATORS ANALYZED 703 PATIENTS UNDER 21 YEARS OF AGE AND OVER 15 KG WHO RECEIVED LVADS BETWEEN 2017 AND 2023, OF WHOM 303 RECEIVED AN HM3 DEVICE. FEMALES ACCOUNTED FOR 31% OF HM3 RECIPIENTS, WITH SIMILAR IMPLANTATION RATES BY GENDER IN PATIENTS WEIGHING UNDER 50 KG, BUT WITH THREE TIMES AS MANY MALES AS FEMALES RECEIVING HM3S IN THE =51 KG GROUP¿A DISPARITY PROPORTIONAL TO OVERALL VAD USE IN THAT WEIGHT CATEGORY. DESPITE THIS DIFFERENCE IN UTILIZATION, THERE WERE NO GENDER-BASED DIFFERENCES IN HM3 OUTCOMES. TABLE 2 DESCRIBED CLINICAL OUTCOMES BY GENDER FOR HM3 PATIENTS WHICH INCLUDES ¿DECEASED, ON DEVICE¿ AND ¿TRANSPLANTED, ALIVE¿. THE FINDINGS MIRROR ADULT TRENDS AND SUGGEST THAT ADULT-SIZED PEDIATRIC FEMALES MAY UNDERGO ADVANCED HEART FAILURE THERAPY LESS FREQUENTLY THAN MALES, UNDERSCORING THE NEED FOR FURTHER RESEARCH INTO POSSIBLE UNDERRECOGNITION OR UNDERTREATMENT OF HEART FAILURE IN FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984670 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death