BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22869825 · Received August 21, 2025

    Report

    Report Number
    2916596-2025-05310
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 13, 2025
    Report Date
    September 16, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM 08JUL20924 THROUGH 04AUG2025. NO NOTABLE EVENTS OR ALARMS ASSOCIATED WITH THE PUMP WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, (B)(6), WITH NO FURTHER RELATED EVENTS REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-017515 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, WARNS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. IF NOT ADDRESSED, THE LVAD WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE 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 THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) ON (B)(6) 2025 WITH ACUTE DYSPNEA. LABORATORY RESULTS INCLUDED B-TYPE NATRIURETIC PEPTIDE (BNP) OF 1818 COMPARED TO 371 ON (B)(6) 2025, INTERNATIONAL NORMALIZED RATIO (INR) OF 5.2, LACTIC ACID OF 1.6, AND POTASSIUM OF 3.1. POINT-OF-CARE ULTRASOUND (POCUS) SHOWED NO EVIDENCE OF PERICARDIAL EFFUSION, BUT THE INFERIOR VENA CAVA (IVC) WAS DILATED. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED AND REVEALED SEVERE AORTIC INSUFFICIENCY (AI) AND WAS UNDER EVALUATION. FOLLOWING REVIEW, ROUTINE LOG FILES APPEARED NORMAL. PER THE SITE, THE AI HAD EXISTED PRIOR TO LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. AN ECHO FROM (B)(6) 2025 SHOWED MODERATE REGURGITATION OF THE AORTIC VALVE, AND AN ECHO FROM (B)(6) 2025 SHOWED SEVERE REGURGITATION. THE ONSET WAS NOTED AS (B)(6) 2025. THE REASON WAS UNSPECIFIED. THE PATIENT WAS ADMITTED, AND DUE TO SEVERE AI AND BEING NOT A CANDIDATE FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), A CARDIOTHORACIC SURGERY EVALUATION WAS PLACED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE CONCLUSION/FINDINGS OF THE CARDIOTHORACIC SURGERY EVALUATION WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661219 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7093825 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention