BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21471708 · Received February 26, 2025

    Report

    Report Number
    2916596-2025-00961
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    June 30, 2018
    Report Date
    February 26, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, 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 30JUN2018 AS TRANSPLANTS OCCURRED FROM 01AUG2012 TO 31JUN2018. AUTHOR INFORMATION: SERVAIS, A., LUNDGREN, S., BOWMAN, S., STOLLER, D., BURDORF, A., HYDEN, M., LOWES, B., ZOLTY, R., KLEPSER, D., & BRINK, H. (2024). PREOPERATIVE AMIODARONE AND PRIMARY GRAFT DYSFUNCTION IN HEART TRANSPLANTATION. ANNALS OF PHARMACOTHERAPY, 58(11), 1099¿1104. HTTPS://DOI.ORG/10.1177/10600280241232032. UNIVERSITY OF NEBRASKA MEDICAL CENTER, OMAHA, NE, USA. 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. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION D IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS, INCLUDING CARDIAC ARRYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATIONS 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 "PREOPERATIVE AMIODARONE AND PRIMARY GRAFT DYSFUNCTION IN HEART TRANSPLANTATION" THAT 22 HEARTMATE 3 PATIENTS UNDERWENT HEART TRANSPLANT, 11 OF WHICH WERE ON AMIODARONE PRE-TRANSPLANT. ATRIAL AND VENTRICULAR ARRHYTHMIAS OCCUR FREQUENTLY IN PATIENTS WITH END-STAGE HEART FAILURE, MANY OF WHOM ARE LISTED OR CURRENTLY BEING EVALUATED FOR ORTHOTOPIC HEART TRANSPLANTATION (OHT). AMIODARONE IS A COMMON ANTIARRHYTHMIC IN THIS POPULATION DUE TO PATIENT COMORBIDITIES AS WELL AS LIMITED EFFICACY AND INCREASED RISK OF ADVERSE EVENTS WITH OTHER AGENTS. THE STUDY RETROSPECTIVELY ANALYZED ELECTRONIC MEDICAL RECORDS OF ALL ADULT OHT RECIPIENTS AGE =18 YEARS OLD BETWEEN 01AUG2012, AND 31JUN2018. TWO-HUNDRED ADULT OHT RECIPIENTS WERE ANALYZED, OF WHOM 112 (56%) RECEIVED PREOPERATIVE AMIODARONE AND 88 (44%) DID NOT. PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) WERE MORE LIKELY TO BE ON PREOPERATIVE AMIODARONE THAN WITHOUT IT (78.6% VS 59%, P = 0.003). MEDIAN DURATION OF LVAD PLACEMENT PRIOR TO TRANSPLANT WAS 270 DAYS (±402) IN THOSE ON PREOPERATIVE AMIODARONE AND 345 DAYS (±465) IN THOSE NOT ON PREOPERATIVE AMIODARONE (P = 0.08).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540364 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