BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25162667 · Received May 13, 2026

    Report

    Report Number
    2916596-2026-2916890
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    October 1, 2024
    Report Date
    May 13, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    117

    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 01 OCTOBER 2024, AS THE DATE OF DATA COLLECTION WAS BETWEEN JANUARY 2015 AND OCTOBER 2024. AUTHOR INFORMATION: CHICKERILLO, K., DESHPANDE, N., BELKIN, M., MERRITT, I., NGUYEN, A., CHUNG, B., KIM, G., GOZDECKI, L., SARSWAT, N., KALANTARI, S., SWAT. S., HUBBELL, A., LABUHN, C., OKRAY, J., MEEHAN, K., KELSO, L., CREIGHTON, S., JUNG, C., WRIGHT, N., OTA, T., JEEVANANDAM, V., SALERNO, C., GRINSTEIN, J., KANELIDIS, A. (2025) STELLATE GANGLION BLOCK AS A THERAPEUTIC OPTION FOR REFRACTORY VENTRICULAR TACHYCARDIA POST-LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION: A CASE SERIES. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44S527 DOI: HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.1133 UNIVERSITY OF CHICAGO, CHICAGO, IL UNIVERSITY OF CHICAGO MEDICINE, CHICAGO, IL UNIVERSITY OF CHICAGO HOSPITAL, CHICAGO, IL UNIVERSITY OF CHICAGO MEDICAL CENTER, CHICAGO, IL MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE 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, WERE DOCUMENTED AS UNKNOWN. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, REV. D IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF 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 ¿STELLATE GANGLION BLOCK AS A THERAPEUTIC OPTION FOR REFRACTORY VENTRICULAR TACHYCARDIA POST-LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION: A CASE SERIES¿ IDENTIFYING THAT HM3 MAY BE RELATED TO REFRACTORY VENTRICULAR TACHYCARDIA. THIS IS A RETROSPECTIVE STUDY, 474 PATIENTS, THAT FOCUSED ON PATIENTS BETWEEN JANUARY2015 AND OCTOBER 2024 WHO UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION THAT WAS COMPLICATED BY REFRACTORY VENTRICULAR TACHYCARDIA (VT) AND WERE TREATED WITH STELLATE GANGLION BLOCK (SGB) THERAPY. FINDINGS SHOWED THAT 10 PATIENTS EXPERIENCED REFRACTORY VT POST-LVAD IMPLANTATION THAT REQUIRED SGB THERAPY. OUT OF THE 474 PATIENTS, 80% WOMEN, 40% BLACK, 40% ISCHEMIC CARDIOMYOPATHY, 90% WERE IMPLANTED WITH A HEARTMATE 3 LVAD, AND 60% HAD A HISTORY OF VT PRIOR TO IMPLANT. ALL PATIENTS WERE ON MULTIPLE INTRAVENOUS ANTI-ARRHYTHMIC AGENTS WITH 90% RECEIVING AMIODARONE, 80% LIDOCAINE, AND 70% PROCAINAMIDE, AND 70% OF PATIENTS REQUIRED INTUBATION AND SEDATION. THE AVERAGE NUMBER OF DEFIBRILLATIONS PRIOR TO SGB WAS 7. SGB WAS PRIMARILY PERFORMED UNILATERALLY ON THE LEFT (70%), AND NO PATIENTS HAD COMPLICATIONS FROM THE SGB. AFTER SGB, 60% DID NOT EXPERIENCE RECURRENT VT. IN THE 40% WITH RECURRENT VT, MEDIAN TIME TO RECURRENCE WAS 2 (0, 8) DAYS AND REQUIRED ADDITIONAL CARDIOVERSION AND PROLONGED IV ANTIARRHYTHMICS. ONE PATIENT WITH RECURRENT VT 8 DAYS AFTER SGB WAS ABLE TO SUCCESSFULLY UNDERGO A VT ABLATION 19 DAYS AFTER LVAD IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137699 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention