BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19044302 · Received April 4, 2024

    Report

    Report Number
    2916596-2024-01761
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    December 27, 2023
    Report Date
    June 14, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    D4: CATALOG NUMBER CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORT OF THE NEED TO DE-AIR THE SYSTEM MULTIPLE TIMES DUE TO AIR IN THE LEFT VENTRICLE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON MLP-042056 WITH NO FURTHER REPORTED ISSUES AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-042056 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 5 ¿SURGICAL PROCEDURES¿ PROVIDES INFORMATION ON ALL SURGICAL PROCEDURES, INCLUDING PRIMING THE PUMP (SUBSECTION ENTITLED ¿PREPARING, RUNNING, AND PRIMING THE PUMP¿) AND DE-AIRING THE PUMP (SUBSECTION ENTITLED ¿DE-AIRING THE PUMP¿). SECTION 5 CONTAINS SEVERAL STEPS TO PREVENT ENTRAPPED AIR AND ENSURE ENTRAPPED AIR IS REMOVED. THE IFU WARNS THAT ALL ENTRAPPED AIR MUST BE REMOVED FROM THE DEVICE TO MINIMIZE THE RISK OF AIR EMBOLUS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOULD BE UTILIZED TO MONITOR FOR AIR EMBOLI. SECTION 5 WARNS THAT PROLONGED DE-AIRATION MAY BE DUE TO INADEQUATE BLOOD SUPPLY TO THE LEFT VENTRICULAR ASSIST DEVICE OR A LEAK IN THE SEALED OUTFLOW GRAFT OR SEALED INFLOW CANNULA. IF AIR PERSISTS IN THE PUMP SEALED OUTFLOW GRAFT FOR A PROLONGED PERIOD (MORE THAN 5¿10 MINUTES), RULE OUT LEAKS AT THE SEALED INFLOW CANNULA/PUMP CONNECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DEAIRING THE SYSTEM DURING IMPLANT, AIR WAS NOTED IN THE LEFT VENTRICLE. THE CAUSE FOR DIFFICULTY OF DEAIRING WAS NOT REPORTED. THE DEAIRING PROCESS WAS REPEATED MULTIPLE TIMES UNTIL NO MORE AIR WAS SEEN. NO LEAK WAS IDENTIFIED. ONCE FULL HEMOSTASIS WAS OBTAINED, THE STERNUM WAS CLOSED. THE EVENT SLIGHTLY INCREASED PROCEDURE TIME AS HEMOSTASIS TIME TOOK LONGER. HOWEVER, NO ADVERSE PATIENT IMPACT WAS REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339334 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 10033508 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown