BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22152626 · Received June 5, 2025

    Report

    Report Number
    2916596-2025-03271
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    August 3, 2023
    Report Date
    June 5, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: AUTHOR INFORMATION: BASHIR H, ET AL. J. CLIN. MED. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS, ARTICLE IN PRESS. HTTPS://DOI.ORG/10.1016/J.JSCAI.2025.103662 THE CHRIST HOSPITAL HEART AND VASCULAR INSTITUTE AND THE LINDNER CENTER FOR RESEARCH AND EDUCATION, CINCINNATI, OHIO, USA A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-013425, AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON THE HEARTMATE 3 LVAS, SERIAL NUMBER MLP-013425, WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-013425 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THE IFU ALSO EXPLAINS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. THIS SECTION ALSO STATES THAT IF THE AORTIC INSUFFICIENCY IS NOT ADDRESSED, THE DEVICE WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. 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 ¿TRANSCATHETER AORTIC VALVE REPLACEMENT FOR AORTIC REGURGITATION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES: AN INSTITUTIONAL EXPERIENCE?¿ IDENTIFYING THAT HM3 MAY BE RELATED TO AORTIC INSUFFICIENCY/REGURGITATION. THIS OBSERVATIONAL STUDY INCLUDED 348 LVAD PATIENTS IMPLANTED FROM JAN2014 TO OCT2024. OF THOSE 348 PATIENTS, 7 (2%) PATIENTS RECEIVED A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR SIGNIFICANT AORTIC REGURGITATION (AR), INCLUDING 5 PATIENTS WITH HM3. PATIENT 5 OF THIS ARTICLE UNDERWENT THE TAVR 1442 DAYS AFTER LVAD IMPLANT. THE PATIENT UNDERWENT THE TAVR DUE TO SEVERE MITRAL REGURGITATION (MR), SEVERE TRICUSPID REGURGITATION (TR), AND SEVERE AR. THE PATIENT WAS DISCHARGED ALIVE WITH NO MR, TR, AR, AND NO POSTPROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400990 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 7069098 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H