BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14026247 · Received April 6, 2022

    Report

    Report Number
    2916596-2022-02008
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    March 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THE IFU STATES THAT PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THIS SECTION ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. 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. THIS SECTION INSTRUCTS THE USER TO VERIFY THAT THE 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 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE REPORT OF A COMPRESSED OUTFLOW GRAFT UNDER THE BEND RELIEF COULD NOT BE CONFIRMED THROUGH THE SUBMITTED IMAGES AND VIDEOS. ADDITIONALLY, THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE PROVIDED FOR REVIEW. A DIRECT CORRELATION BETWEEN THE OUTFLOW GRAFT OBSTRUCTION AND THE REPORTED ALARMS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    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 WAS TAKEN TO THE OR DUE TO PERSISTENT LOW FLOW ALARMS AND A SUSPECTED OUTFLOW GRAFT (OFG) TWIST VS OFG COMPRESSION IN THE BEND RELIEF. THIS WAS NOTED ON A COMPUTERIZED TOMOGRAPHY (CT) SCAN PERFORMED ON THE PATIENT'S CHEST. LEFT THORACOTOMY WAS PERFORMED AND THE OFG BEND RELIEF WAS EXPLORED WITH A SUCTION CATHETER AFTER IT WAS DISCONNECTED AT THE PROXIMAL AT THE PUMP. A YELLOW THICK FATTY-LOOKING SUBSTANCE WAS SUCTIONED OUT OF THE AREA BETWEEN THE OFG AND BEND RELIEF. ONCE THE SUCTIONING BEGAN, IT WAS NOTED THAT THE PATIENT'S FLOW IMMEDIATELY RECOVERED FROM 2.0LPM TO 4.4LPM. WHEN THE SURGEON ATTEMPTED TO DISENGAGE THE OFG BEND RELIEF FROM THE PUMP, IT WAS NOTED THAT THE OFG WAS NOT PRESENT ON ORIGINAL OPERATIVE NOTE. AFTER ENGAGING THE BEND RELIEF BACK INTO POSITION, THE SURGEON PLACED A NEW OFG CLIP INTO THE PUMP. IT WAS REPORTED THAT THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND THAT ALL EQUIPMENT WILL BE RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443555 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 6078489 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R