BEUDAMED
    FDA Adverse Event Death Summary report: N

    HST III SYSTEM (3.8MM)

    MDR report key: 23623957 · Received November 21, 2025

    Report

    Report Number
    2242352-2025-0001220
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVENT SITE NAME EXCEEDED CHARACTER LIMITATIONS: (B)(6). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    TW #: (B)(4). UPDATED SECTIONS: B4, D9, E1, G3, G6, H2, H3, H6, H11. CORRECTED SECTION: H6: DEVICE CODE CHANGED TO 1669. THE LOT # 3000497963 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED DURING A MITRAL VALVE AND CABBAGE PROCEDURE, THAT THREE PROXIMAL SEALS WERE LOADED AND DEPLOYED INTO THE PROXIMAL AORTIC ANASTOMOTIC SITE. THE HEARTSTRINGS WOULD NOT DEPLOY INTO THE ANASTOMOSIS. ALL THREE FAILED. THE SEAL DID NOT LEAVE THE TUBE (DELIVERY TUBE). FURTHERMORE, THERE WAS AN AORTIC DISSECTION NOT YET CONFIRMED TO BE RELATED DIRECTLY TO HEARTSTRING. APPROPRIATE STEPS WERE TAKEN TO STABILIZE THE PATIENT INCLUDING UTILIZING ECMO SUPPORT. THE PATIENT WAS SCHEDULED BACK 10/28 FOR COMPLETION OF THE SURGERY. THE SURGEON BELIEVES IT WAS THE AORTIC CUTTER THAT DISSECTED THE AORTA. THE CUTTER WAS USED WHEN THE IATROGENIC DISSECTION OCCURRED. SIGNIFICANT BLEEDING OCCURRED. A CLAMP WAS USED TO COMPLETE THE ANASTOMOSIS, AFTER THE DISSECTION AND FAILURE OF HEART STRINGS. ECMO SUPPORT WAS USED FOR CIRCULATORY SUPPORT DUE TO THE HEART, BEING IN AN EXHAUSTED STATE. THERE WAS A PROCEDURAL DELAY. ON 10/28 THE PATIENT WAS TAKEN BACK TO THE OR TO COMPLETE CLOSING THE CHEST AND CLEAN OUT THE CAVITY. THE PATIENT'S HAS EXPIRED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303126 HST III SYSTEM (3.8MM) CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HSK-3038 3000497963 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death