BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10599727 · Received September 29, 2020

    Report

    Report Number
    2916596-2020-04583
    Event Type
    Death
    Date Received
    September 29, 2020
    Date of Event
    March 1, 2010
    Report Date
    March 31, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE II AND 3 LVAS AND THE REPORTED PATIENT DEATHS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. A RESEARCH ARTICLE WAS RECEIVED, WHICH REPORTED THE FOLLOWING INFORMATION. CARDIOPULMONARY EXERCISE TESTING (CPET) IS THE CLINICAL STANDARD TO SELECT HF PATIENTS FOR CARDIAC REPLACEMENT THERAPY. INTERMACS PROFILE IS USED TO RISK STRATIFY PATIENTS WHO UNDERGO LVAD. THE AIM OF THIS STUDY WAS TO EVALUATE THE ASSOCIATION OF CPET PERFORMANCE PARAMETERS WITH INTERMACS PROFILE AT IMPLANT AS WELL AS WITH CLINICAL OUTCOMES EARLY POST LVAD. THEY STUDIED 81 PATIENTS AND THE MEDIAN TIME FROM CPET TO LVAD IMPLANT WAS 233 DAYS. SIX (6) PATIENTS DIED. PVO2 AND VE/VCO2 WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN INTERMACS =2 VS >2 GROUPS (P=0.8 AND P=0.15, RESPECTIVELY). ROC CURVES SHOWED THAT PVO2 < 12.8 ML/KG/MIN HAD A SENSITIVITY OF 53% AND SPECIFICITY OF 85% FOR THE POST LVAD COMPOSITE ENDPOINT (AUC 0.66, P=0.02), WHILE VE/VCO2 WAS NOT A SIGNIFICANT PREDICTOR. LOS WAS LONGER IN PATIENTS WITH PVO2 < MEDIAN (33 [39] VS 22[7]D, P < 0.001) AND VE/VCO2 = MEDIAN (30[29] VS 22[8]D, P=0.01). IT CONCLUDED THAT THESE FINDINGS SUGGEST THAT IN A REAL-WORLD SETTING, CPET PARAMETERS OBTAINED WITHIN 2 YEARS OF LVAD DO NOT RELIABLY PREDICT INTERMACS PROFILE AT IMPLANT. HOWEVER, PVO2 AND VE/VCO2 CAN BE HELPFUL TO IDENTIFY PATIENTS AT RISK FOR IN-HOSPITAL MORTALITY, MAJOR COMPLICATIONS AND PROLONGED LOS POST LVAD. THE HEARTMATE 3 LVAS IFU, REV. C AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING DEATH. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT ¿PRE LVAD CPET AS PREDICTOR OF INTERMACS PROFILE AND EARLY OUTCOMES POST LVAD¿ IDENTIFYING THAT THE HEARTMATE 3 MAY BE RELATED WITH POST LVAD IN-HOSPITAL MORTALITY, RIGHT VENTRICULAR FAILURE (RVF) AND RENAL REPLACEMENT THERAPY (RRT). THIS STUDY EVALUATED 81 LVAD PATIENT, 40% HM3, AND 60% OTHER PUMPS. IT IS A RETROSPECTIVE ANALYSIS OF LVAD PATIENTS IMPLANTED FROM 3/10 TO 5/19 WITH CARDIOPULMONARY EXERCISE TESTING DATA AVAILABLE WITHIN 2 YEARS OF SURGERY: PEAK OXYGEN CONSUMPTION (PVO2) AND MINUTE VENTILATION-CARBON DIOXIDE PRODUCTION RELATIONSHIP (VE/VCO2). THE PRIMARY ENDPOINTS WERE INTERMACS PROFILE =2 AT IMPLANT AND A COMPOSITE OF POST LVAD IN-HOSPITAL MORTALITY, RVF AND RRT. A TOTAL OF 6 PATIENTS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063681 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 Death