BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20693757 · Received November 15, 2024

    Report

    Report Number
    2916596-2024-07590
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    September 1, 2021
    Report Date
    January 16, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1 - BRAND NAME: CORRECTED. SECTION D4 - CATALOG NUMBER: CORRECTED. SECTION D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: CORRECTED. SECTION E1 - REPORTER NAME: CORRECTED. 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. DIVISION OF CARDIOTHORACIC SURGERY, DEPARTMENT OF SURGERY, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY, USA HIDEYUKI HAYASHI ET AL., INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY. 2023/10/01. HTTP://DX.DOI.ORG/10.1093/ICVTS/IVAD168. MANUFACTURER'S INVESTIGATION CONCLUSION: THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS DEVICE MALFUNCTIONS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A1: PATIENT INFORMATION IS UNKNOWN. D1: DEVICE INFORMATION IS UNKNOWN. REFERENCE: HIDEYUKI HAYASHI ET AL., INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC. SURGERY. 2023/10/01. HTTP://DX.DOI.ORG/10.1093/ICVTS/IVAD168.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿DOES LATERAL APPROACH PRESERVE THE RIGHT VENTRICULAR (RV) FUNCTION AFTER HEARTMATE3 INSERTION¿ IDENTIFYING THAT HEARTMATE3 (HM3) MAY BE RELATED TO RIGHT VENTRICULAR FAILURE (RVF) AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT, TRICUSPID REGURGITATION, AND DEATH. THIS STUDY COMPARED THE 1-MONTH AND 1-YEAR RV FUNCTION AND GEOMETRY USING ECHOCARDIOGRAM AFTER HEARTMATE 3 IMPLANTATION VIA LATERAL THORACOTOMY (LT) OR STERNOTOMY. THIS RETROSPECTIVE STUDY INCLUDED PATIENTS WHO UNDERWENT HM3 IMPLANTATION BETWEEN NOVEMBER 2014 AND SEPTEMBER 2021. THE EXCLUSION CRITERIA WERE THE PATIENTS WHO: (1) RECEIVED RIGHT VENTRICULAR ASSIST DEVICES (RVADS) INTRAOPERATIVELY; (II) HAD A HISTORY OF TRICUSPID VALVE (TV) SURGERY; OR (III) HAD UNDERGONE CONCOMITANT TV SURGERY AT THE TIME OF LVAD IMPLANTATION. THE PRIMARY OUTCOME WAS ALL-CAUSE MORTALITY. THE SECONDARY OUTCOME WAS A COMPOSITE OF DEATH OR READMISSION DUE TO WORSENING RVF WITHIN 2 YEARS OF IMPLANTATION. OF THE 195 PATIENTS INCLUDED IN THE ANALYSIS, 55 (28%) UNDERWENT LT AND 140 (72%) UNDERWENT STERNOTOMY. A TOTAL OF 24 PATIENTS DIED, AND THE CAUSES OF DEATH WERE SEPSIS AND/OR MULTIORGAN DYSFUNCTION [11 PATIENTS (LT: N = 1, STERNOTOMY: N = 10)], QUALITY OF LIFE CONCERNS [3 PATIENTS (LT: N = 1, STERNOTOMY: N = 2)], DEVICE FAILURE [3 PATIENTS (LT: N = 1, STERNOTOMY: N = 2)], STROKE [3 PATIENTS (LT: N = 0, STERNOTOMY: N = 3)], WITHDRAWAL OF CARE DUE TO ADVANCED CANCER [2 PATIENTS (LT: N = 0, STERNOTOMY: N = 2)], BLEEDING [1 PATIENT (LT: N = 1, STERNOTOMY: N = 0)] AND UNKNOWN [1 PATIENT (LT: N = 0, STERNOTOMY: N = 1)]. THE RESULTS ALSO REVEALED THAT THE LT GROUP PRESERVED BETTER RV FUNCTION AND GEOMETRY 1 MONTH AFTER LVAD IMPLANTATION THAN THOSE OF THE STERNOTOMY GROUP. HOWEVER, THESE DIFFERENCES WERE NOT OBSERVED AT THE 1-YEAR FOLLOW-UP, AND THERE WERE NO SIGNIFICANT DIFFERENCES IN THE 2-YEAR SURVIVAL AND RVF RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285814 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown