BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21509829 · Received March 3, 2025

    Report

    Report Number
    2916596-2025-01073
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    January 1, 2022
    Report Date
    April 10, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2022 AS PATIENTS WERE IMPLANTED BETWEEN 2015 AND 2022. SECTION D4: MODEL NUMBER AND CATALOG NUMBER CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION D, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS THE ADVERSE EVENTS, INCLUDING INFECTION, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DEPARTMENT OF CARDIOVASCULAR SURGERY AND TRANSPLANTOLOGY, JAGIELLONIAN UNIVERSITY, MEDICAL COLLEGE, ST. JOHN PAUL II HOSPITAL, WASILEWSKI, G., WISNIOWSKA-SMIALEK, S., GÓRKIEWICZ-KOT, I., MILANIAK, I., KALETA, M., HYMCZAK, H., WASILEWSKA, A., & WIERZBICKI, K. (2024). DRIVELINE INFECTION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES IMPLANTED AS DESTINATION THERAPY. TRANSPLANTATION PROCEEDINGS, 56(4), 860¿863. HTTPS://DOI.ORG/10.1016/J.TRANSPROCEED.2024.03.029. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE, "DRIVELINE INFECTION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES IMPLANTED AS DESTINATION THERAPY" THAT ONE OF THE MOST COMMON COMPLICATIONS FOLLOWING IMPLANTATION WITH THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS DRIVELINE INFECTIONS (DLIS). 120 PATIENTS IMPLANTED BETWEEN 2015 AND 2022 WITH THE HEARTWARE (47 PATIENTS) AND HEARTMATE 3 (73 PATIENTS) LVADS WERE EXAMINED FOR THIS STUDY. MORE THAN HALF OF THE PATIENTS (N=52; 58%) EXPERIENCED A DRIVELINE INFECTION. THE MEDIAN TIME FOR THE FIRST DRIVELINE INFECTION WAS 13 MONTHS. THE MOST COMMON PATHOGEN REVEALED IN WOUND SWAB CULTURES WAS METHICILLIN-SENSITIVE STAPHYLO-COCCUSAUREUS (N=23; 44%), PSEUDOMONAS AERUGINOSA (N=9; 17%), PROTEUS MIRABILIS (N=4; 7%), AND OTHERS. DEEPER DRIVELINE IMPLANTATION BELOW THE LEFT RECTUS MUSCLE AND JUST ABOVE THE POSTERIOR RECTUS SHEATH RESULTED IN FEWER DLIS AND LONGER FREE-FROM-DLI FOLLOW-UP TIME. IN 11 PATIENTS (21%), THE DRIVELINE INFECTION WAS COMPLICATED BY A BLOODSTREAM INFECTION. IN ALL CASES, THE PATIENTS WITH DRIVELINE INFECTIONS WERE ADMITTED TO THE HOSPITAL AND TREATED WITH TARGETED ANTIBIOTICS AND ADVANCED WOUND CLEANING. THERE WERE A FEW CASES THAT REQUIRED EXTENSIVE WOUND DEBRIDEMENT. THE MEDIAN STAY IN THE INTENSIVE CARE UNIT WAS 6 DAYS AND THE MEDIAN TIME OF EXTUBATION AFTER THE PROCEDURE WAS 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586098 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R