BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23842970 · Received December 18, 2025

    Report

    Report Number
    2916596-2025-08124
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 16, 2025
    Report Date
    February 9, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    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: THE REPORTED OUTFLOW GRAFT OBSTRUCTION COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS NO IMAGES WERE SUBMITTED FOR REVIEW, AND THE DEVICE REMAINS IN USE. A SPECIFIC CAUSE FOR THE REPORTED OBSTRUCTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CAPTURED THE PUMP FUNCTIONING AS INTENDED. THE PERIODIC LOG FILE CAPTURED A DOWNTREND IN FLOW THROUGHOUT THE FILE. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT FINDINGS UPON CHEST COMPUTED TOMOGRAPHY AORTOGRAM (CTA). THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) HAD A NONOCCLUSIVE ECCENTRIC THROMBUS/BIODEBRIS IN THE PROXIMAL OUTFLOW CONDUIT TRACT ADJACENT TO THE APEX END WITH APPROXIMATELY 50% NARROWING, WHICH HAD WORSENED WHEN COMPARED TO 17APR2022 WHEN IT WAS PRESENT WITH LESS THAN 50% NARROWING. NO ACUTE PULMONARY DISEASE WAS IDENTIFIED. THERE WERE MULTIPLE PULSATILITY INDEX (PI) EVENTS IDENTIFIED UPON INTERROGATION, WITH AN OVERALL DOWN TREND IN CALCULATED FLOW OVER TIME AND RECENT SPEED CHANGE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL (B)(6), WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP", INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 5, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." SECTION 5, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE". 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 HAD SIGNIFICANT FINDINGS UPON CHEST COMPUTED TOMOGRAPHY AORTOGRAM (CTA). THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) HAD A NONOCCLUSIVE ECCENTRIC THROMBUS/BIODEBRIS IN THE PROXIMAL OUTFLOW CONDUIT TRACT ADJACENT TO THE APEX END WITH APPROXIMATELY 50% NARROWING, WHICH HAD WORSENED WHEN COMPARED TO (B)(6) 2022 WHEN IT WAS PRESENT WITH LESS THAN 50% NARROWING (CS-221467). NO ACUTE PULMONARY DISEASE WAS IDENTIFIED. THERE WERE MULTIPLE PULSATILITY INDEX (PI) EVENTS IDENTIFIED UPON INTERROGATION, WITH AN OVERALL DOWN TREND IN CALCULATED FLOW OVER TIME AND RECENT SPEED CHANGE. FOLLOWING REVIEW OF THE SUBMITTED LOG FILES, IT APPEARED THAT THERE WERE 128 PU EVENTS WITHIN ABOUT AN HOUR AND 20 MINUTE PERIOD. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT APPEARED TO HAVE OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423564 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6605486 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other