BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25187240 · Received May 15, 2026

    Report

    Report Number
    2916596-2026-2916785
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    August 1, 2023
    Report Date
    May 15, 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
    003

    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. DATE OF EVENT HAS BEEN ENTERED AS 01AUG2023, SINCE THE DATE OF DATA COLLECTION OCCURRED BETWEEN JANUARY 2019 AND AUGUST 2023. AUTHOR INFORMATION: UNIVERSITY OF NEBRASKA MEDICAL CENTER, OMAHA, NE S. LUNDGREN, ET AL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION 44 (2025) 44(4): S424. DOI: 10.1016/J.HEALUN.2025.02.911. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE STUDY FOUND THAT A MULTIDISCIPLINARY GDMT OPTIMIZATION CLINIC FOR PATIENTS POST-LVAD IMPROVES GDMT USE AND MAY LEAD TO IMPROVED POST IMPLANT OUTCOMES. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LVAS IFU, REV. D IS CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND BLEEDING, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT,¿ (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. 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 ¿IMPROVEMENT IN POST-LVAD OUTCOMES UTILIZING A VAD OPTIMIZE CLINIC¿ IDENTIFYING THAT THE HEARTMATE 3 (HM WAS ASSOCIATED WITH RIGHT HEART FAILURE AND GASTROINTESTINAL (GI) BLEEDING. THIS STUDY EVALUATED THE IMPACT OF A 12-WEEK CLINIC DESIGNED TO OPTIMIZE GUIDELINE DIRECTED MEDICAL THERAPY (GDMT) POST- LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON GDMT USE AND OUTCOMES. A MULTIDISCIPLINARY WAS DEVELOPED AND ENROLLED PATIENTS AFTER DISCHARGE FROM LVAD IMPLANTATION. THE CLINIC CONSISTED OF 6 VISITS, TWO WEEKS APART AND INCLUDED MEDICATION OPTIMIZATION AS WELL AS NUTRITION AND PHARMACY COUNSELING. BETWEEN JANUARY 2019 AND AUGUST 2023, A TOTAL OF 44 PATIENTS COMPLETED VAD OPTIMIZATION CLINIC. THE COMPARISON GROUP INCLUDED 71 LVAD PATIENTS. THE AVERAGE TIME TO ENROLLMENT WAS 46 (± 20) DAYS POST-IMPLANT. AT THE END OF OPTIMIZE, THERE WAS A SIGNIFICANT IMPROVEMENT IN QUADRUPLE GDMT UTILIZATION COMPARED TO STANDARD OF CARE POPULATION. FEWER PATIENTS EXPERIENCED RECURRENT (2 OR MORE) HOSPITALIZATIONS WITHIN 6 MONTHS OF LVAD IMPLANT COMPARED TO STANDARD OF CARE (P=0.02). THERE WAS A TREND TOWARDS REDUCTION IN RIGHT VENTRICULAR (RV) FAILURE (P=0.13) AND RECURRENT HEART FAILURE (HF) HOSPITALIZATIONS (P=0.11). BOTH GROUPS PRESENTED WITH GI BLEEDING, BUT NO DIFFERENCE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562173 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O