BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21374606 · Received February 13, 2025

    Report

    Report Number
    2916596-2025-00658
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    November 1, 2016
    Report Date
    February 13, 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: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN NOVEMBER 2016 TO MAY 2020. SILESIAN CENTER FOR HEART DISEASES, ZABRZE, POLAND; AND DEPARTMENT OF CARDIAC, VASCULAR, AND ENDOVASCULAR SURGERY AND TRANSPLANTOLOGY, MEDICAL UNIVERSITY OF SILESIA, KATOWICE, POLAND. ANTONCZYK, R., BIELKA, A., KALINOWSKI, M., SMIGIEL-IRAS, M., & KUCZAJ, A. (2024). THE RESULTS OF MINIMALLY INVASIVE IMPLANTATION OF THE HEARTMATE 3 LVAD LEFT VENTRICULAR ASSIST DEVICE. TRANSPLANTATION PROCEEDINGS, 56(4), 854¿859. HTTPS://DOI.ORG/10.1016/J.TRANSPROCEED.2024.03.024. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. 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. G, ARE CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS BLEEDING, INFECTION, AND RIGHT HEART FAILURE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING THE INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿THE RESULTS OF MINIMALLY INVASIVE IMPLANTATION OF THE HEARTMATE 3 LVAD LEFT VENTRICULAR ASSIST DEVICE¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH INCREASED INTRAOPERATIVE USE OF FRESH FROZEN PLASMA (FFP) (P = .02) AND PLATELET CONCENTRATES (PCS), POSTOPERATIVE BLEEDING, POSTOPERATIVE WOUND INFECTIONS, OTHER INFECTIOUS COMPLICATIONS, POSTOPERATIVE RIGHT VENTRICULAR FAILURE, AND DEATH. THIS RETROSPECTIVE STUDY EVALUATED 47 PATIENTS WHO UNDERWENT THE HEARTMATE 3 LVAD IMPLANTATION BY STERNOTOMY AND 26 PATIENTS WHO HAD HEARTMATE 3 IMPLANTED VIA MINIMALLY INVASIVE METHOD. THE OBSERVATION LASTED FROM NOV2016 TO MAY2020. SIGNIFICANTLY HIGHER INTRAOPERATIVE USE OF FFP (P = .02) AND PCS (P = .01) WAS OBSERVED AMONG PATIENTS TREATED WITH THE MINIMALLY INVASIVE METHOD. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE NUMBER OF POSTOPERATIVE BLEEDINGS REQUIRING SURGICAL INTERVENTION BETWEEN THE STUDY GROUPS. HOWEVER, THERE WAS A TENDENCY FOR MORE FREQUENT POSTOPERATIVE BLEEDINGS THAT REQUIRED TRANSFUSIONS BUT NOT SURGERY AMONG PATIENTS TREATED WITH MINIMALLY INVASIVE ACCESS. 6% OF PATIENTS WHO UNDERWENT STERNOTOMY EXPERIENCED POSTOPERATIVE WOUND INFECTIONS COMPARED TO 0% IN THE MINIMALLY INVASIVE APPROACH GROUP. OTHER INFECTIOUS COMPLICATIONS DID NOT DIFFER SIGNIFICANTLY BETWEEN THE GROUPS. 10 PATIENTS (21.28%) WHO UNDERWENT STERNOTOMY EXPERIENCED POSTOPERATIVE RIGHT VENTRICULAR FAILURE AND 4 PATIENTS (15.38%) WHO UNDERWENT THE MINIMALLY INVASIVE APPROACH EXPERIENCED POSTOPERATIVE RIGHT VENTRICULAR FAILURE. THERE WAS NO SIGNIFICANT DIFFERENCE IN SURVIVAL BETWEEN THE GROUPS. THE MEAN SURVIVAL TIME AMONG PATIENTS UNDERGOING STERNOTOMY WAS 430.0 DAYS (+/- 291.77 DAYS). PATIENTS UNDERGOING MINIMALLY INVASIVE SURGERY HAD A MEAN SURVIVAL TIME OF 633.15 DAYS (+/- 426.84). THERE WAS NO SIGNIFICANT DIFFERENCE IN ONE 1 YEAR SURVIVAL BETWEEN GROUPS (84% VS 84%, P = .24).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118832 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other