BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 25260542 · Received May 22, 2026

    Report

    Report Number
    2916596-2026-2917141
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    June 1, 2024
    Report Date
    May 22, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN JUL2018 AND JUN2024. TSAO, C., YUNG, Y., CHI, N., WANG, C., HUANG, S., YU, H., HSU, R., HWANG, S., & CHEN, Y. (2025). UNPLANNED HOSPITAL READMISSIONS AND DISCHARGE SURVIVAL BETWEEN HEARTMATE 3 AND HEART TRANSPLANT IN TAIWAN. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.1149 NATIONAL TAIWAN UNIVERSITY HOSPITAL, TAIPEI, TAIWAN. MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 TITLED ¿UNPLANNED HOSPITAL READMISSIONS AND DISCHARGE SURVIVAL BETWEEN HEARTMATE 3 AND HEART TRANSPLANT IN TAIWAN¿ THAT THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE ASSOCIATED WITH DEATH AND INFECTION. ADULT PATIENTS (=18 YEARS) WHO RECEIVED HM3 OR HEART TRANSPLANT (HT) FROM JUL2018 TO JUN2024 AT NATIONAL TAIWAN UNIVERSITY HOSPITAL WERE RETROSPECTIVELY ANALYZED. ALL RECIPIENTS WERE TREATED PER A STANDARD PROTOCOL AND REGULARLY FOLLOWED UP. 114 PATIENTS WERE INCLUDED, 50 IN THE HM3 GROUP AND 64 IN THE HT GROUP. THE MEAN AGE WAS 50.9 YEARS. THE 3-YEAR DISCHARGE SURVIVAL RATES SHOWED NO SIGNIFICANT DIFFERENCE (76.8% FOR HM3 VS. 88.3% FOR HT; P=0.88). HOWEVER, THE 90-DAY UNPLANNED READMISSION RATES DIFFERED SIGNIFICANTLY (HM3: 38% VS. HT: 21.9%; P=0.047). OVERALL, 68.0% OF HM3 PATIENTS AND 62.5% OF HT PATIENTS HAD UNPLANNED READMISSIONS OVER A MEDIAN FOLLOW-UP OF 786 DAYS. THE AVERAGE NUMBER OF READMISSIONS PER PATIENT WAS 2.0 FOR HM3 AND 1.6 (SD 2.0) FOR HT (P=0.313). INFECTIONS WERE THE MOST COMMON REASON FOR HOSPITALIZATION (HM3: 52.4%, HT: 47.6%; P > 0.05), WITH HM3 PATIENTS SHOWING INCREASED DRIVELINE WOUND INFECTIONS POST-DISCHARGE, WHILE HT PATIENTS PRIMARILY HAD RESPIRATORY INFECTIONS. OTHER INFECTIONS IN THE HM3 GROUP INCLUDED URINARY TRACT INFECTION, STERNAL WOUND, PNEUMONIA, GASTROENTERITIS, EPIDIDYMITIS, COVID-19, CELLULITIS, AND BLOOD STEAM INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321198 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization