BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22056184 · Received May 20, 2025

    Report

    Report Number
    2916596-2025-02854
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    January 1, 2021
    Report Date
    May 23, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. REQUEST FOR THIS INFORMATION HAS BEEN MADE. DEVICE WAS IMPLANTED AT TIME OF EVENT. B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2021 AS PATIENTS WERE IMPLANTED BETWEEN 2015 AND 2021. D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. UPPALAPATI, L., ET AL. (2025). OUTCOMES IN HEART MATE 3 RECIPIENTS WITH PRE-EXISTING ATRIAL FIBRILLATION. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 85(12), 1378. HTTPS://DOI.ORG/10.1016/S0735-1097(25)01862-5. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORT OF ATRIAL FIBRILLATION COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE REPORTED HEART TRANSPLANTS COULD NOT BE CONCLUSIVELY DETERMINED. NO DEVICES WERE RETURNED FOR THIS EVALUATION. THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED AND WERE UNABLE TO BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (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 ARTICLE 'OUTCOMES IN HEARTMATE 3 RECIPIENTS WITH PRE-EXISTING ATRIAL FIBRILLATION' THAT A RETROSPECTIVE STUDY WAS DONE FROM A SINGLE CENTER FROM 2015 TO 2021 THAT INCLUDED 54 PATIENTS WHO WERE IMPLANTED WITH HEARTMATE 3; 25 PATIENTS HAD NO PRIOR ATRIAL FIBRILLATION (AF) AND 29 HAD AF PRIOR TO IMPLANT. POST-IMPLANT ATRIAL FIBRILLATION (POAF) INCIDENCE WAS 28% IN THE PRE-IMPLANT ATRIAL FIBRILLATION PRAF GROUP AND 31% IN THOSE WITHOUT PRAF (P=0.81). THERE WAS NO DIFFERENCE IN TIME TO POAF ONSET (HR 1.06, P=0.92) OR 5-YEAR SURVIVAL (HR 1.29, P=0.58) BETWEEN GROUPS. 6 PATIENTS WERE TRANSPLANTED, 2 THAT HAD NO PRAF AND 4 THAT HAD PRAF (P=0.5). 22 PATIENTS PASSED AWAY, 8 THAT HAD NO PRAF AND 14 THAT HAD PRAF (P=0.23).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26327 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