BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 17844837 · Received September 29, 2023

    Report

    Report Number
    2916596-2023-07041
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    February 28, 2022
    Report Date
    September 29, 2023
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LVAS (LEFT VENTRICULAR ASSIST SYSTEM) AND THE REPORTED EVENTS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE IS CURRENTLY AVAILABLE AND CONTAINS THE FOLLOWING INFORMATION: SECTION 1 OUTLINES POTENTIAL ADVERSE EVENTS, INCLUDING RESPIRATORY FAILURE, CARDIAC ARRHYTHMIA, BLEEDING, AND STROKE, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 LISTS CARDIAC ARRHYTHMIA AS A POTENTIAL LATE POST-IMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT 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

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿MORTALITY AND MORBIDITY BURDEN OF COVID-19 INFECTION IN LEFT VENTRICULAR ASSIST DEVICE PATIENTS¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH RESPIRATORY FAILURE, ARRHYTHMIA, BLEEDING, STROKE, AND DEATH. THIS RETROSPECTIVE COHORT STUDY EVALUATED OUTCOMES OF COVID-19 INFECTION IN PATIENTS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICES (LVADS). A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH AN LVAD WERE SCREEN FOR COVID-19 BETWEEN 0(B)(6) 2019 AND (B)(6) 2022. 68 EVENTS OF COVID-19 INFECTION WERE IDENTIFIED AMONG 64 PATIENTS; 3 PATIENTS WERE NOTED TO TEST POSITIVE FOR COVID-19 TWICE, AND THESE WERE COUNTED AS SEPARATE EVENTS. OF THESE 64 PATIENTS, 55 WERE IMPLANTED WITH HM3. 12 HEARTMATE II AND 4 HVAD PATIENTS WERE ALSO INCLUDED IN THE ANALYSIS RESULTS. RESULTS REVEALED 6 HM3 PATIENTS PASSED AWAY WHILE INFECTED WITH COVID-19. RESULTS ALSO REPORTED SEVERAL OUTCOMES WHILE PATIENTS WERE INFECTED WITH COVID-19; OUTCOMES WERE NOT BROKEN DOWN BY LVAD TYPE. 5 PATIENTS WERE INTUBATED AND 6 PATIENTS DEVELOPED CHRONIC HYPOXIC RESPIRATORY FAILURE THAT REQUIRED OUTPATIENT SUPPLEMENTAL OXYGEN. 4 PATIENTS EXPERIENCED VENTRICULAR TACHYCARDIA, AND 3 PATIENTS EXPERIENCED IMPLANTED CARDIOVERTER DEFIBRILLATION SHOCKS. 9 PATIENTS EXPERIENCED EPISTAXIS OR GASTROINTESTINAL (GI) BLEEDING WITHIN ONE MONTH OF TESTING POSITIVE FOR COVID-19. 3 PATIENTS HAD A STROKE. THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR. REPORT # 2916596-2023-03725. SERIOUS INJURIES ARE CAPTURED UNDER THIS REPORT AND DEATH IS CAPTURED UNDER MFR. REPORT # 2916596-2023-03725.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278638 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| R