BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11088873 · Received December 29, 2020

    Report

    Report Number
    2916596-2020-06254
    Event Type
    Death
    Date Received
    December 29, 2020
    Date of Event
    August 1, 2015
    Report Date
    January 22, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE SOURCE: A BANSAL, ET AL. JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOLUME: 39, ISSUE: 4, PAGES: S411. DOI: 10.1016/J.HEALUN.2020.01.185, OCHSNER CLINIC FOUNDATION, NEW ORLEANS, LA. SECTION G6: "30-DAY" WAS INADVERTENTLY NOT CHECKED IN THE PRIOR REPORT. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED, ¿POST -APPROVAL EXPERIENCE WITH FULLY MAGNETICALLY LEVITATED CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICE- SINGLE CENTER EXPERIENCE¿, WAS RECEIVED. THE STUDY SOUGHT TO COMPARE 1-YEAR SURVIVAL AMONG PATIENTS WHO WERE IMPLANTED WITH HEARTMATE (HM) 3 DEVICES DURING THE MOMENTUM 3 CLINICAL TRIAL AND THOSE WHO WERE IMPLANTED DURING THE POST-APPROVAL COMMERCIAL PHASE. A TOTAL OF 149 PATIENTS WHO WERE IMPLANTED WITH AN HM3 DEVICE AT A SINGLE CENTER BETWEEN AUG2015 AND AUG2019 WERE INCLUDED IN THIS STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: 82 PATIENTS IMPLANTED DURING THE CLINICAL TRIAL, AND 67 PATIENTS IMPLANTED DURING THE COMMERCIAL PHASE. BOTH GROUPS WERE CLINICALLY COMPARABLE DESPITE THE COMMERCIAL GROUP CONSISTING OF MORE PATIENTS IMPLANTED AS DESTINATION THERAPY AND CLASSIFIED AS INTERMACS PROFILE 1 AND 2. THE STUDY RESULTED IN 1-YEAR SURVIVAL FOR 94.7% OF THE COMMERCIAL GROUP COMPARED TO THE 93.9% OF THE TRIAL GROUP. THE STUDY CONCLUDED THAT DESPITE THE COMMERCIAL GROUP HAVING A HIGHER DEGREE OF HEART FAILURE AND COMORBID CONDITIONS, 1-YEAR SURVIVAL WAS SIMILAR TO THAT OF THE TRIAL GROUP. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE / PATIENT INFORMATION, ARE NOT AVAILABLE. THE HM3 LVAS IFU LISTS DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 ¿POST-APPROVAL EXPERIENCE WITH FULLY MAGNETICALLY LEVITATED CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICE- SINGLE CENTER EXPERIENCE¿ IDENTIFYING THAT HEARTMATE 3 MAY BE RELATED TO DEATH. THIS RETROSPECTIVE STUDY EVALUATED AND COMPARED 1-YEAR SURVIVAL BETWEEN PATIENTS WHO RECEIVED HEARTMATE 3 DURING THE MOMENTUM 3 CLINICAL TRIAL VS. POST APPROVAL COMMERCIAL PHASE. A TOTAL OF 149 PATIENTS UNDERGOING HEARTMATE 3 IMPLANT BETWEEN AUG2015 AND AUG2019 WAS CARRIED OUT AND DIVIDED INTO 2 GROUPS: TRIAL (N=67, 44.97%) VS. COMMERCIAL (N=82, 55.03%). NO DIFFERENCES WERE FOUND BETWEEN THE 2 GROUPS: RATES OF 1-YEAR SURVIVAL WERE 94.7% VS. 93.9% FOR COMMERCIAL AND TRAIL ARM RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551447 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H