BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21520362 · Received March 4, 2025

    Report

    Report Number
    2916596-2025-01192
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    December 1, 2021
    Report Date
    April 11, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    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 01DEC2021 AS PATIENTS WERE IMPLANTED BETWEEN OCTOBER 2015 AND DECEMBER 2021. 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. WISNIOWSKA-SMIALEK, S., KALETA, M., RUBIS, P., WIERZBICKI, K., GÓRKIEWICZ-KOT, I., & WASILEWSKI, G. (2024). CLINICAL CHARACTERISTIC OF LVAD RECIPIENTS REQUIRED OVER AND LOWER THAN MEDIAN DOSAGE OF LOOP DIURETIC DURING 12 MONTHS FOLLOWING THE IMPLANTATION. KARDIOLOGIA POLSKA, 82, 166-167. DOI:HTTP://DX.DOI.ORG/10.33963/V.PHJ.102611 NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    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 HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RENAL DYSFUNCTION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION B, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS THE ADVERSE EVENTS, INCLUDING RENAL DYSFUNCTION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. 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 "CLINICAL CHARACTERISTIC OF LVAD RECIPIENTS REQUIRED OVER AND LOWER THAN MEDIAN DOSAGE OF LOOP DIURETIC DURING 12 MONTH FOLLOWING THE IMPLANTATION" THAT 30 PATIENTS DIED DURING THE STUDY. THE STUDY AIMED TO DETERMINE WHICH CLINICAL OR LABORATORY FACTORS AT BASELINE MAY PREDICT HIGHER DOSAGE OF LOOP DIURETICS (LD) DURING 12 MONTHS FOLLOWING THE IMPLANTATION. BETWEEN OCTOBER 2015 AND DECEMBER 2021 YEAR 113 PATIENTS HAVE BEEN IMPLANTED WITH LVAD IN A SINGLE CENTER IN POLAND. MEDIAN AGE OF THE STUDY POPULATIONS WAS 57.2 ± 10.1 YEARS AND THERE WERE 94.6% MEN. AFTER 12 MONTHS OF OBSERVATIONS THERE WERE 83 PATIENTS ALIVE (73.5%) AND 30 PATIENTS DIED (26.5 %). 41% OF AMBULATORY CARE PATIENTS REQUIRED OVER MEDIAN DOSAGE OF BOTH LD DURING THE FIRST 12 MONTHS FOLLOWING THE IMPLANTATION. THERE WERE NO DIFFERENCES IN TERMS OF AGE [57 (50-64) VS. 63 (52-66), P = 0.44]; GENDER AND TYPE OF LVAD (61.8 VS. 53.2% HEART MATE3, P = 44) BETWEEN GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447730 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention