BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21462565 · Received February 25, 2025

    Report

    Report Number
    2916596-2025-00931
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    August 1, 2024
    Report Date
    March 25, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. TITLE: 25 YEARS OF LEFT VENTRICULAR ASSIST DEVICES IN PERTH BAUMWOL, J., SILBERT, B., SHAH, A., DEMBO, L., HAYES, H., MCLEAN, J., & LARBALESTIER, R. (2024). 25 YEARS OF LEFT VENTRICULAR ASSIST DEVICES IN PERTH. HEART LUNG AND CIRCULATION, 33, S242. HTTPS://DOI.ORG/10.1016/J.HLC.2024.06.244. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE CORRECTED. SECTION D1: BRAND NAME CORRECTED. SECTION D4: MODEL NUMBER AND CATALOG NUMBER CORRECTED. SECTION E: REPORTER INFORMATION CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. SECTION H6: HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE CORRECTED. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. B, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING INFECTION (LOCAL, DRIVELINE, OR PUMP POCKET), STROKE, AND BLEEDING. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. THIS SECTION ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. 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 "25 YEARS OF LEFT VENTRICULAR ASSIST DEVICES IN PERTH" THAT HEARTMATE 3 MAY BE ASSOCIATED WITH INFECTION, GASTROINTESTINAL BLEEDING, STROKE, AND DEATH. THE STUDY REVIEWED THE OUTCOMES OF THE WESTERN AUSTRALIAN LVAD PROGRAM. 158 LEFT VENTRICULAR ASSIST DEVICES (LVADS) HAVE BEEN IMPLANTED IN 25 YEARS, OF WHICH 106 WERE NEWER GENERATION DEVICES (INCLUDING HEARTMATE 3). ALMOST ALL PATIENTS (92%) WERE CLASSED AS BRIDGE-TO-TRANSPLANT OR -CANDIDACY/DECISION, WITH THE REMAINDER CLASSED ¿DESTINATION THERAPY¿ (DT). MEAN LV EJECTION FRACTION WAS 20% AND 33% HAD SEVERE RIGHT VENTRICULAR DYSFUNCTION. SIXTY-THREE PERCENT OF PATIENTS HAD A NON-ISCHAEMIC CARDIOMYOPATHY. FOLLOWING LVAD IMPLANT THE MEDIAN LENGTH OF STAY IN INTENSIVE CARE WAS 2 DAYS, AND IN HOSPITAL OVERALL 23 DAYS. NINETY-SIX PERCENT SURVIVED TO HOSPITAL DISCHARGE, AND FOLLOWING DISCHARGE 97% OF DAYS WITH LVAD WERE SPENT AS AN OUTPATIENT. THE MEDIAN NUMBER OF HOSPITAL READMISSIONS WAS 1.6 PER PATIENT PER YEAR. LVAD-ASSOCIATED INFECTION REQUIRING ADMISSION OR INTRAVENOUS ANTIBIOTICS AT ANY TIME POST-IMPLANT OCCURRED IN 36%, SIGNIFICANT GASTROINTESTINAL BLEEDING IN 19%, AND STROKE IN 9%. THE PERCENTAGE OF PATIENTS ALIVE WITH LVAD STILL IN SITU AT 1, 2, AND 5 YEARS WAS 92%, 88%, AND 68%, RESPECTIVELY. ALL DT PATIENTS SURVIVED AT LEAST 4 YEARS, SPENDING 97% OF DAYS WITH LVAD AS AN OUTPATIENT, AND FOUR DT PATIENTS HAVE SURVIVED FOR AT LEAST 10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088380 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R