BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25308858 · Received May 27, 2026

    Report

    Report Number
    2916596-2026-2916969
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 1, 2024
    Report Date
    May 27, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN JULY 2020 - APRIL 2024. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. AUTHOR INFORMATION: LADANYI, A., VOLLMER, B., DELUTY, S., ALONZO, G., MURPHY, B., MAYER, S., SHAHIDI, C., CAREY, M. R., FIDLOW, K. M., URIEL, N., SAYER, G., TAKEDA, K., WILLEY, J., YUZEFPOLSKAYA, M., COLOMBO, P., & PAVOL, M. (2025). PREDICTION OF SELF-MANAGEMENT AND DRIVELINE INFECTION FOR HEARTMATE 3 LVAD. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.985. DEPARTMENT OF CARDIOLOGY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY; 2 COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY; 3 DEPARTMENT OF CARDIOLOGY, NEW YORK PRESBYTERIAN HOSPITAL, NEW YORK, NY; 4 DEPARTMENT OF NEUROLOGY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY; 5 DEPARTMENT OF CARDIOLOGY, BRIGHAM & WOMEN'S HOSPITAL, BOSTON, MA; 6 DEPARTMENT OF SURGERY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY. 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 THAT MANAGEMENT OF A LEFT VENTRICULAR ASSIST DEVICE IS COMPLEX, AND DRIVELINE INFECTION (DLI) REMAINS A COMMON COMPLICATION. THE ARTICLE "PREDICTION OF SELF-MANAGEMENT AND DRIVELINE INFECTION FOR HEARTMATE 3 LVAD" IDENTIFYING THAT HEARTMATE 3 MAY BE RELATED TO AN INFECTION, REPORTS A RETROSPECTIVE STUDY OF 109 ENGLISH-SPEAKING PATIENTS IMPLANTED WITH A HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) BETWEEN (B)(6) 2020 TO (B)(6) 2024. THIS STUDY EXAMINED SOCIAL AND COGNITIVE PREDICTORS OF PATIENT SELF-MANAGEMENT (SM) AND THEIR ASSOCIATION WITH DLI IN INDIVIDUALS SUPPORTED BY THE HEARTMATE 3 LVAD. PRE-LVAD ASSESSMENTS INCLUDED CAREGIVER AVAILABILITY, TRANSPORTATION, SUBSTANCE USE, MENTAL HEALTH, HOUSING, AND COGNITIVE FUNCTIONING (MEMORY, VISUAL-MOTOR CODING SPEED, AND EXECUTIVE FUNCTION). LVAD SM WAS RATED AT HOSPITAL DISCHARGE AND DLI OCCURRENCE WAS ASSESSED WITHIN 2 YEARS POST IMPLANT USING FACTOR ANALYSES AND LASSO REGRESSION MODELS. THE COHORT HAD A MEAN AGE OF 61±13 YEARS, MEAN EDUCATION LEVEL OF 13±3 YEARS, 92 (84%) PATIENTS WERE MALE, AND 61 (56%) HAD AN INTERMACS SCORE OF 1-2. THE MEDIAN FOLLOW UP-TIME WAS 521 ± 224 DAYS. INDEPENDENT LVAD SELF-MANAGEMENT WAS ACHIEVED BY 72 (64%) PATIENTS. CAREGIVER AND TRANSPORTATION PROBLEMS WERE FOUND FOR 25 (23%) AND 15 (14%) OF PATIENTS, RESPECTIVELY. FACTOR ANALYSES IDENTIFIED CAREGIVER, TRANSPORTATION, CODING, AND STORY RECALL SCORES FOR POTENTIAL INCLUSION. LASSO LOGIT REGRESSION FOR PREDICTION OF LVAD SM RETAINED AGE, EDUCATION, AND CODING VARIABLES WITH THE LARGEST CONTRIBUTIONS FROM AGE AND CODING. LASSO COX PROPORTIONAL HAZARDS REGRESSION FOR PREDICTING DLI RETAINED AGE, INTERMACS, AND TRANSPORTATION VARIABLES WITH THE LARGEST CONTRIBUTION FROM AGE. OVERALL, AGE, EDUCATION, AND VISUAL-MOTOR CODING SPEED MAY INFORM PREDICTION OF LVAD SM AT HOSPITAL DISCHARGE WHILE AGE, INTERMACS SCORE, AND TRANSPORTATION PROBLEMS MAY INFORM PREDICTION OF DLI AFTER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536354 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention