BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13056166 · Received December 21, 2021

    Report

    Report Number
    2916596-2021-07160
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 19, 2021
    Report Date
    February 9, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED BLEEDING, CARDIAC ARRHYTHMIA, AND PERIPHERAL THROMBOEMBOLISM 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. THE HEARTMATE 3 LVAS IFU, REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS BLEEDING, CARDIAC ARRHYTHMIA, AND VENOUS THROMBOEMBOLISM AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES, AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. THIS DOCUMENT FURTHER INSTRUCTS THE USER TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW PRIOR TO ADVANCING THE INFLOW CANNULA AND TO ADDRESS BOTH AS NEEDED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON 30OCT2021. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD POST OPERATION BLEEDING AND ANEMIA. THE PATIENT RECEIVED ONE UNITE OF PACKED RED BLOOD CELLS (PRBCS). SINUS TACHYCARDIA WAS ALSO NOTED WITH HEARTRATE IN THE LOW 100'S. MEAN ARTERIAL PRESSURE (MAP) WAS IN THE 70'S ON VASOPRESSIN AT .06 UNITS PER HOUR. RIGHT ATRIAL FIBRILLATION (RAF) WITH HEARTRATE UP TO 154 BEATS PER MINUTE WAS NOTED ON (B)(6) 2021. 500 MILLILITERS OF FLUID BOLUS AND AMIODARONE BOLUS WERE ADMINISTERED. AN AMIODARONE DRIP WAS STARTED TO TREAT THE ARRHYTHMIA, CAUSING THE PATIENT'S HEART RATE TO DROP TO 100-110 BEATS PER MINUTE. A CHEST X-RAY ON (B)(6) 2021 SHOWED LEFT LOWER LOBE COLLAPSE AND SMALL LEFT PLEURAL EFFUSION. BILATERAL LOWER EXTREMITY DUPLEX ON (B)(6) 2021 WAS NEGATIVE FOR DEEP VEIN THROMBOSIS (DVT). LEFT UPPER EXTREMITY (LUE) SWELLING AND LEFT SUBCLAVIAN DVT WAS CONFIRMED ON (B)(6) 2021 WITH BILATERAL UPPER EXTREMITY DUPLEX. BILATERAL LOWER EXTREMITY PITTING EDEMA WAS NOTED ON (B)(6) 2021. AN ADDITIONAL CHEST X-RAY ON (B)(6) 2021 SHOWED NO CHANGE OR SLIGHT IMPROVEMENT TO LEFT PLEURAL EFFUSION. THE PATIENT WAS ON ROOM AIR AND HAD NO SHORTNESS OF BREATH. A THORACENTESIS WAS DONE ON (B)(6) 2021 WITH IMPROVEMENT. THE PATIENT WAS DISCHARGED ON (B)(6) "202" ON DIGOXIN AND CONTINUED ON WARFARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950949 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 8059747 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R