BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21207964 · Received January 22, 2025

    Report

    Report Number
    2916596-2025-00161
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    May 3, 2024
    Report Date
    January 22, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ESTABLISHED THROUGH THIS EVALUATION. THE REPORTED LOW FLOW EVENTS, WHICH THE ACCOUNT ATTRIBUTED TO SPEED CHANGES IMPLEMENTED DUE TO AORTIC INSUFFICIENCY, COULD NOT BE CONFIRMED AS NO LOG FILES FROM THE EVENT DATE WERE SUBMITTED FOR REVIEW AND THE DEVICE REMAINS IN USE. FURTHERMORE, THE REPORTED CLOT COULD NOT BE CONFIRMED AS NO IMAGES WERE SUBMITTED FOR REVIEW AND THE DEVICE REMAINS IN USE; A SPECIFIC CAUSE FOR THE CLOT COULD NOT BE CONCLUSIVELY DETERMINED. THE SUBMITTED LOG FILES DID NOT CONTAIN DATA FROM THE REPORTED EVENT DATE OF 03MAY2024. THESE LOG FILES WERE PREVIOUSLY SUBMITTED UNDER CS-193492. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEVICE THROMBOSIS, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS SECTION ALSO PROVIDES AN EXPLANATION OF PUMP PARAMETERS, INCLUDING FLOW. THIS SECTION EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS SECTION ALSO NOTES THAT, IN GENERAL, THE MAGNITUDE OF THE PULSATILITY INDEX (PI) VALUE IS RELATED TO THE AMOUNT OF ASSISTANCE PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (I.E., THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). SECTION 5, ¿SURGICAL PROCEDURES¿, EXPLAINS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. THIS SECTION ALSO STATES THAT IF THE AORTIC INSUFFICIENCY IS NOT ADDRESSED, THE DEVICE WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ADDITIONALLY, THIS SECTION, UNDER ¿ANTICOAGULATION¿ PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, DESCRIBES ALARM CONDITIONS (INCLUDING THE LOW FLOW HAZARD), AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. 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 SEEN IN THE CLINIC ON 03MAY2024 WITH COMPLAINTS OF INTERMITTENT CHEST PAIN IN THE LOWER STERNAL AREA (DULL, 2/10). THEY ALSO REPORTED SHORTNESS OF BREATH WITH ACTIVITY, DIZZINESS, BLURRED VISION, INCOORDINATION, NAUSEA, FATIGUE, AND WEAK AND THREADY PULSE. LOG FILE REVIEW WAS REQUESTED, AND THE EVENT LOG FILE CONTAINED LOW FLOW ESTIMATES AS WELL AS SUSTAINED LOW FLOW HAZARD EVENTS WHEN THE CALCULATED PULSATILITY INDEX (PI) WAS ELEVATED. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. IT WAS COMMUNICATED ON 26JUN2024 THAT THERE WERE NO MORE REPORTED SYMPTOMS SINCE THE INITIAL EVENT, AND THAT THE CAUSE OF THE CHEST PAIN WAS UNKNOWN. THE PATIENT WAS STATED TO BE DOING WELL. IT WAS STATED THAT THE LOW FLOW ALARMS RESOLVED, AND THAT THE PATIENT WAS TO HAVE AN ECHOCARDIOGRAM (ECHO) PERFORMED. IT WAS ADDITIONALLY CONFIRMED ON (B)(6) 2024 THAT THE PATIENT EXPERIENCED A CLOT ON (B)(6) 2024. A COMPUTED TOMOGRAPHY (CT) WAS DONE. THE CLOT WAS STATED TO HAVE RESOLVED ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572735 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 8593058 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other