BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21816560 · Received April 10, 2025

    Report

    Report Number
    2916596-2025-02242
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    April 1, 2023
    Report Date
    August 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    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. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION 01APR2023 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. MOLINA, E. J., AHMED, M. M., SHEIKH, F. H., CLEVELAND, J. C., JR, GOLDSTEIN, D. J., URIEL, N. Y., WANG, A., REVIS, J. J., & MEHRA, M. R. (2024). LEFT VENTRICULAR DIMENSIONS AND CLINICAL OUTCOMES WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE. JACC. HEART FAILURE, S2213-1779(24)00779-0. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JCHF.2024.09.019. PIEDMONT HEART INSTITUTE, ATLANTA, GEORGIA, USA, UNIVERSITY OF FLORIDA, GAINESVILLE, FLORIDA, USA, MEDSTAR WASHINGTON HOSPITAL CENTER, GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE, WASHINGTON, DC, USA, UNIVERSITY OF COLORADO SCHOOL OF MEDICINE, AURORA, COLORADO, USA, MONTEFIORE EINSTEIN CENTER FOR HEART AND VASCULAR CARE, NEW YORK, NEW YORK, USA, COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS AND NEW YORK-PRESBYTERIAN HOSPITAL, NEW YORK, NEW YORK, USA, ABBOTT, ABBOTT PARK, ILLINOIS, USA, BRIGHAM AND WOMEN¿S HOSPITAL HEART AND VASCULAR CENTER, HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA. 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 DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU REV. D AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. 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 ¿LEFT VENTRICULAR DIMENSIONS AND CLINICAL OUTCOMES WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH RIGHT HEART FAILURE, INFECTION, STROKE, BLEEDING, ARRYTHMIAS, MEDICAL/SURGICAL INTERVENTION, LOW FLOW, OTHER CARDIAC DISORDERS, NEUROLOGICAL DYSFUNCTION, THROMBOSIS, ANTI-COAGULATION RELATED ADVERSE EVENTS, RESPIRATORY FAILURE, RENAL DYSFUNCTION, HYPERTENSION RELATED ADVERSE EVENTS, SEPSIS, AND DEATH. THIS RETROSPECTIVE STUDY EVALUATED 1921 PATIENTS. THE STUDY AIMED TO EXAMINE THE ASSOCIATION OF SMALLER LEFT VENTRICULAR END-DIASTOLIC DIAMETER(LVEDD) WITH CLINICAL OUTCOMES. PATIENTS WITH MISSING LVEDD VALUES OR WITH ERRONEOUS BASELINE DATA WERE EXCLUDED FROM THE STUDY GROUP. THE PATIENT POPULATION WAS SPLIT BETWEEN THOSE WITH A SMALLER LVEDD (<55 MM) (N=108) AND THOSE WITH A LARGER LVEDD (>55MM) (N=1813) THE AVERAGE AGE OF PATIENTS WITH A SMALLER LVEDD WAS OLDER (63 +/- 11 YEARS) THAN THE AVERAGE AGE OF PATIENTS WITH A LARGER LVEDD (60 +/- 10 YEARS, P=0.005). PATIENTS WITH A SMALLER LVEDD WERE MORE OFTEN FEMALE (30.6%) COMPARED TO PATIENTS WITH A LARGER LVEDD(19.8%). OUT OF THE TOTAL 1921 EVALUATED PATIENTS, A TOTAL OF 338 PATIENTS PASSED AWAY. 66 PATIENTS PASSED AWAY DUE TO HEMOCOMPATIBILITY RELATED ADVERSE EVENTS. THE SITE CONSIDERED STROKE, BLEEDING, AND PUMP THROMBOSIS TO BE HEMOCOMPATIBILITY RELATED ADVERSE EVENTS, BUT THE BREAKDOWN BETWEEN THESE TYPES OF ADVERSE EVENTS WAS NOT REPORTED IN THE ARTICLE. 43 PATIENTS PASSED AWAY DUE TO MAJOR INFECTIONS, 130 PASSED AWAY DUE TO RIGHT HEART FAILURE. 119 PATIENTS PASSED AWAY PRIOR TO DISCHARGE AFTER IMPLANTATION. ADDITIONALLY, THE ARTICLE ALSO SITED NUMEROUS ADVERSE EVENTS EXPERIENCED BY THE PATIENT GROUP. THERE WERE 166 PATIENTS WHO EXPERIENCED A STROKE, OF WHICH 80 PATIENTS EXPERIENCED A HEMORRHAGIC STROKE, 96 PATIENTS EXPERIENCED AN ISCHEMIC STROKE, AND 79 PATIENTS EXPERIENCED A DEBILITATING STROKE. THERE WERE 666 PATIENTS WHO EXPERIENCED A CARDIAC ARRYTHMIA, OF WHICH 328 PATIENTS EXPERIENCED A SUPRAVENTRICULAR CARDIAC ARRYTHMIA, 374 PATIENTS EXPERIENCED A VENTRICULAR ARRYTHMIA, AND 37 EXPERIENCED BOTH. THERE WERE 932 PATIENTS WHO EXPERIENCED A MAJOR BLEEDING EVENT, OF WHICH 538 PATIENTS EXPERIENCED GASTROINTESTINAL BLEEDING, AND 243 REQUIRED SURGERY DUE TO THE BLEEDING. THERE WERE 1090 PATIENTS WHO EXPERIENCED AN INFECTION, OF WHICH 435 PATIENTS EXPERIENCED A DRIVELINE INFECTION, AND 287 PATIENTS EXPERIENCED SEPSIS. THERE WERE 108 PATIENTS WHO EXPERIENCED A HYPERTENSION ADVERSE EVENT. THERE WERE 289 PATIENTS WHO EXPERIENCED RENAL DYSFUNCTION. THERE WERE 384 PATIENTS WHO EXPERIENCED RESPIRATORY FAILURE THERE WERE 715 PATIENTS WHO EXPERIENCED RIGHT HEART FAILURE, OF WHICH 119 PATIENTS WERE TREATED WITH AN IMPLANTED RIGHT VENTRICLE ASSIST DEVICE (RVAD), AND 115 PATIENTS RECEIVED AN RVAD BEFORE INDEX DISCHARGE. THERE WERE ALSO 23 PATIENTS WITH SUSPECTED DEVICE THROMBOSIS. ADDITIONALLY, THE ARTICLE ALSO REPORTED NUMEROUS REASONS FOR REHOSPITALIZATIONS FOR PATIENTS WHILE ON THE HEARTMATE 3. IN TOTAL 1582 PATIENTS WERE HOSPITALIZED FOR ANY REASON. THERE WERE 517 REHOSPITALIZATIONS WITH BLEEDING AS THE PRIMARY CAUSE. THERE WERE 469 REHOSPITALIZATIONS WITH MEDICAL OR SURGICAL PROCEDURES AS THE PRIMARY CAUSE. THERE WERE 232 REHOSPITALIZATIONS WITH ANTICOAGULATION AS THE PRIMARY CAUSE. THERE WERE 566 REHOSPITALIZATIONS WITH MAJOR INFECTION AS THE PRIMARY CAUSE. THERE WERE 335 REHOSPITALIZATIONS WITH HEART FAILURE RELATED EVENTS AS THE PRIMARY CAUSE. THERE WERE 157 REHOSPITALIZATIONS WITH LOW FLOWS AS THE PRIMARY CAUSE. THERE WERE 248 REHOSPITALIZATIONS WITH CARDIAC ARRHYTHMIA AS THE PRIMARY CAUSE. THERE WERE 274 REHOSPITALIZATIONS WITH OTHER CARDIAC DISORDERS AS THE PRIMARY CAUSE. THERE WERE 152 REHOSPITALIZATIONS WITH NEUROLOGICAL DYSFUNCTION AS THE PRIMARY CAUSE. THERE WERE 274 REHOSPITALIZATIONS DUE TO OTHER UNSPECIFIED CARDIAC DISORDERS. THERE WERE 9 REHOSPITALIZATIONS DUE TO DEVICE THROMBOSIS. THERE WERE 790 REHOSPITALIZATIONS FOR OTHER UNSPECIFIED REASONS. FINALY IT WAS REPORTED THAT PUMP EXCHANGE DUE TO DEVICE MALFUNCTION OCCURRED. THE STUDY CONCLUDED THAT SMALLER LVEDD WAS ASSOCIATED WITH INCREASED RISK FOR EARLY AND LATE MORTALITY, PRIMARILY AS A RESULT OF HEMOCOMPATIBILITY RELATED AND RIGHT HEART FAILURE RELATED DEATHS. IN ADDITION, RE-HOSPITALIZATIONS DUE TO LOW FLOWS WAS ALSO MORE COMMON IN SMALLER LVEDD PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415687 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown