BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 24082317 · Received January 15, 2026

    Report

    Report Number
    2916596-2026-00294
    Event Type
    Death
    Date Received
    January 15, 2026
    Date of Event
    September 1, 2022
    Report Date
    January 15, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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. KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTER. DAWARY, M., ALBERT-BROTONS, D., & TSAI, F. W. (2026). SHORT-TERM OUTCOMES OF PEDIATRIC HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE: SINGLE CENTER EXPERIENCE. EUROPEAN SOCIETY OF CARDIOLOGY HEART FAILURE. HTTPS://DOI.ORG/10.1093/ESCHF/XVAF017 . MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEVICE THROMBOSIS, STROKE, BLEEDING, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. THIS SECTION ALSO INSTRUCTS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. 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. SECTION 6 OF THE IFU (UNDER "ONGOING PATIENT ASSESSMENT AND CARE") LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATIONS. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE 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 ¿SHORT-TERM OUTCOMES OF PEDIATRIC HEARTMATE3 LEFT VENTRICULAR ASSIST DEVICE: SINGLE CENTER EXPERIENCE¿ THAT HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE ASSOCIATED WITH STROKE, BLEEDING, INFECTION, DEVICE THROMBOSIS, RIGHT VENTRICULAR FAILURE, AND DEATH. THE STUDY EVALUATES THE SHORT-TERM OUTCOMES OF HM3 LVAD PEDIATRIC PATIENTS IN THE FIRST PEDIATRIC HM3 LVAD PROGRAM IN SAUDI ARABIA. THE STUDY WAS A RETROSPECTIVE COHORT DESIGN INVOLVING 15 PEDIATRIC PATIENTS. THE PATIENTS WERE MANAGED AT A SINGLE TERTIARY REFERRAL CARDIAC CENTER BETWEEN SEPTEMBER 2022 AND JUNE 2024. PATIENTS OVER 14 YEARS OLD AND THOSE WITH LVADS OTHER THAN HM3 WERE EXCLUDED FROM THE STUDY. ALL PATIENTS UNDERWENT HM3 IMPLANTATION VIA MEDIAN STERNOTOMY AND CARDIOPULMONARY BYPASS. THE MEDIAN CARDIOPULMONARY BYPASS (CPB) TIME WAS 132 MINUTES. ONE PATIENT REQUIRED AN AORTIC CROSS-CLAMP PERIOD TO REMOVE A LEFT VENTRICULAR CLOT. THE MEDIAN INTENSIVE CARE UNIT (ICU) STAY POST IMPLANT WAS 42 DAYS AND THE MEDIAN HOSPITAL STAY WAS 56 DAYS. POSTOPERATIVE COMPLICATIONS INCLUDED STROKE IN TWO PATIENTS, BLEEDING REQUIRING RE-EXPLORATION IN ONE PATIENT, PNEUMONIA IN TWO PATIENTS, DRIVELINE INFECTION IN TWO PATIENTS, AND DEVICE THROMBOSIS IN ONE PATIENT. NINE PATIENTS HAD REDUCED RIGHT VENTRICULAR DYSFUNCTION. IN-HOSPITAL MORTALITY WAS REPORTED IN TWO PATIENTS: ONE EXPERIENCED ISCHEMIC STROKE WITH HEMORRHAGIC CONVERSION AND THE SECOND EXPERIENCED DEVICE THROMBOSIS 18 DAYS AFTER SURGERY. NINE OUT OF 15 PATIENTS UNDERWENT SUCCESSFUL HEART TRANSPLANT WITHIN A MEDIAN OF NINE MONTHS. ONE-YEAR SURVIVAL RATE WAS 87%. THE STUDY CONCLUDED THAT HM3 LVADS HAVE FAVORABLE SAFETY PROFILES AND SURVIVAL OUTCOMES IN PEDIATRIC PATIENTS WITH END-STAGE HEART FAILURE. THESE FINDINGS SUPPORT HM3 AS A VIABLE OPTION FOR MANAGING ADVANCED HEART FAILURE IN THE SAUDI PEDIATRIC POPULATION, WITH FURTHER STUDIES WARRANTED TO ASSESS LONG-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142128 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention