BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16372577 · Received February 14, 2023

    Report

    Report Number
    2916596-2023-00713
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    December 3, 2021
    Report Date
    February 24, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    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. VOLUNTARY MW NUMBER 3400300000-2021-0000040 WAS RECEIVED 26JAN2023.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED THROMBUS AND OUTFLOW GRAFT OBSTRUCTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS INVESTIGATION AS NO PHOTOS OR IMAGES WERE SUBMITTED AND THE PUMP REMAINS IN USE. THE REPORT OF LOW FLOW ALARMS CAN BE CONFIRMED BASED ON THE ONSITE EVALUATION BY AN ABBOTT REPRESENTATIVE. SINCE THE UPGRADE, NO FURTHER ALARMS HAVE BEEN REPORTED. 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) WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT SHIPPED ON (B)(6) 2019. THE HEARTMATE 3 LVAS IFU REV. C LISTS PUMP THROMBOSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 6 ALSO CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE SYSTEM MONITOR SECTION OF THE IFU DESCRIBES THE PUMP FLOW DISPLAY AND PULSATILITY INDEX (4-12 THROUGH 4-16) AND THE HAZARD ALARMS (4-18 AND 4-30). THIS DOCUMENT STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM (7-7 AND 7-11). THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS THAT PRIOR TO IMPLANTATION, THE BEND RELIEF SHOULD BE DISENGAGED FROM THE GRAFT FOR THE DE-AIRING PROCEDURE. SECTION 5 ALSO CONTAINS A SUB-SECTION ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP", INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW 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 5, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." THIS SECTION ALSO EXPLAINS HOW TO ATTACH THE BEND RELIEF ONCE THE VENT NEEDLE HAS BEEN REMOVED FROM THE SEALED OUTFLOW GRAFT AND LEAKS HAVE BEEN RULED OUT. SECTION 1 LISTS THE OUTFLOW GRAFT CLIP AS A REQUIRED COMPONENT FOR IMPLANT. SECTION 5, FURTHER INSTRUCTS THE USER TO ¿ATTACH THE OUTFLOW GRAFT CLIP TO PREVENT POST-OPERATIVE OUTFLOW GRAFT TWISTING¿ AND WARNS THAT FAILURE TO INSTALL THE OUTFLOW GRAFT CLIP SO THAT IT IS FLUSH WITH THE BEND RELIEF CAN ALLOW GRAFT TWISTING OR ABRASION WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS BLEEDING, GRAFT OCCLUSION, THROMBOSIS, AND/OR DEATH. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS ALSO CURRENTLY AVAILABLE. SECTION 5 OF THIS HANDBOOK, ENTITLED "ALARMS AND TROUBLESHOOTING," DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    VOLUNTARY MEDWATCH WAS RECEIVED THAT STATES THE PATIENT WAS ADMITTED (B)(6) 2021 WITH LOW FLOW ALARMS, FATIGUE, AND WEAKNESS. PUMP FLOW WAS 2.6 LITERS PER MINUTE (LPM) AND POWER READ 3.9 WATTS. THE PATIENT WAS TAKING WARFARIN AS PRESCRIBED WITH AN INTERNATIONAL NORMALIZED RATIO (INR) RANGE OF 1.5-2.5. AN ECHOCARDIOGRAM ON ADMISSION SHOWED A SMALL LEFT VENTRICLE AND THE CANNULA ABUTTING THE SEPTUM. COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2021 FOUND A NON-OCCLUSIVE THROMBUS AND STENOSIS WITH KINKS TO THE OUTFLOW GRAFT. THE PATIENT WAS STARTED ON HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809998 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6949737 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention| H