BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22497822 · Received July 14, 2025

    Report

    Report Number
    2916596-2025-04440
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ABBOTT MEDICAL-CARDIOMEMS
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    SECTION B2 CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES SHOWED NORMAL OPERATION OF THE SYSTEM. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE DEVICE APPEARED TO OPERATE AS INTENDED AT THE SET SPEED. 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 LVAS WITH NO FURTHER RELATED EVENTS REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, "INTRODUCTION," LISTS POTENTIAL ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS, INCLUDING HEMOLYSIS, RESPIRATORY FAILURE, AND RENAL DYSFUNCTION. SECTION 6 OF THE IFU PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. 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 INTERMITTENT BROWN URINE OVER THE LAST THREE WEEKS. LABORATORY RESULTS WERE NOTABLE FOR ACUTE LUNG INJURY (ALI), ACUTE KIDNEY INJURY (AKI), AND AN ELEVATED PLASMA CELL-FREE HEMOGLOBIN (CFH). THERE WERE NO NOTABLE POWER SPIKES OR LOW FLOW ALARMS. THE SITE SENT LOG FILES TO RULE OUT ANY POSSIBILITY OF PUMP THROMBUS. FOLLOWING REVIEW, LOG FILES DID NOT CONTAIN ATTRIBUTES WHICH WOULD LEAD TO SUSPECT OBSTRUCTION. THE EVENTS DID NOT APPEAR TO HAVE BEEN CAUSED BY ANY TYPE OF EXTERNAL MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399774 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ ABBOTT MEDICAL-CARDIOMEMS 106524US 7067720 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| O