BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11826353 · Received May 14, 2021

    Report

    Report Number
    2916596-2021-02242
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 27, 2021
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6) , AND NO FURTHER RELATED ISSUES HAVE BEEN REPORTED AT THIS TIME. 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), REV. C LISTS CARDIAC ARRHYTHMIA AND PERIPHERAL THROMBOEMBOLIC EVENT AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AND THROMBOEMBOLISM AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS. SECTION 6 ALSO OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN (INCLUDING INR RANGE) FOR PATIENTS USING THE HEARTMATE 3 LVAS AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THE REPORTED ANEMIA WITH A START DATE OF (B)(6) 2021 RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT DEVELOPED WIDE COMPLEX TACHYCARDIA (WCT) POST-OPERATION. THE ELECTROPHYSIOLOGIST (EP) WAS ASKED TO INTERROGATE THE DEVICE. VENTRICULAR TACHYCARDIA (VT) AT 155 BPM FOR 6 MINUTES AND 50 SECONDS CHANGES. VT THERAPIES WERE SET AT A HIGHER RATE TO MINIMIZE SHOCKS. BURST THERAPIES WERE INCREASED TO TREAT TACHYARRHYTHMIAS. EPISODE OF VENTRICULAR TACHYCARDIA (V-TACH) TIMES 5MIN, DECREASED DOBUTAMINE TO 5 FROM 7.5 MCG/KG/MIN (MVO2 73.7) PLACED PADS, BROKE WITHOUT SHOCKING. STARTED ON AMIO DROPS AT 1. ON (B)(6) 2021, HE PATIENT¿S BASELINE HEMOGLOBIN (HGB) 16 G/DL AND 47.2 % HEMATOCRIT (HCT). DOWN TRENDING POST OP (B)(6) 2021 10.9 G/DL /33 %. ,(B)(6) 2021 10.9 G/DL 33.3%, (B)(6) 2021 10.4G/DL 31.1%, AND (B)(6) 2021 10.7G/DL /32% WITHOUT SIGNS OF OVERT BLEEDING. ON (B)(6) 2021, DECREASING PLATELET COUNT BASELINE (B)(6) 2021 293. (B)(6) 2021 PLATELET 156 AND DOWN TRENDING. (B)(6) 2021 PLATELET 130. EVENT REPORTED AS THROMBOCYTOPENIA. ON (B)(6) 2021, ECHO THERE WAS THROMBUS IN THE NON-CORONARY SINUS OF VALSALVA INCREASE HEPARIN GOAL TO PARTIAL THROMBOPLASTIN TIME (PTT) 45-60. HYPONATREMIA (B)(6) 2021, BASELINE NA 137 DOWNTRENDING (B)(6) 2021 NA 129 THE PATIENT¿S REPORTED ANEMIA STARTED (B)(6) 2021 RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. PATIENT WAS WITHDRAWN FROM STUDY AND REQUIRED ANTIPLATELET THERAPY. ON (B)(6) 2021 SUBCUTANEOUS EMPHYSEMA ON AM CHEST X-RAY ON LEFT. ON (B)(6) 2021 CHEST TUBE PLACED BY COMPUTED TOMOGRAPHY (CT) SURGERY FOR AIR LEAK IN WHICH TREATMENT INCLUDED SURGERY. ARTERIAL PERIPHERAL THROMBOEMBOLISM AND CARDIAC ARRHYTHMIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722240 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7846847 00813024013297

    Patients

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