BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20392350 · Received October 7, 2024

    Report

    Report Number
    2916596-2024-06403
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    January 1, 2022
    Report Date
    November 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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 ABSTRACT. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE CORRECTED. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS AN ESTIMATED DATE ¿ (B)(6) 2022 ¿ SINCE THE DATES OF DATA COLLECTION OCCURRED BETWEEN 2017 AND 2022. SECTION G2: REPORT SOURCE CORRECTED. SECTION H6: HEALTH EFFECT - IMPACT CODE CORRECTED. AUTHOR INFORMATION: AUSTIN KLUIS ET AL. SURGERY IN PRACTICE AND SCIENCE 17 (2024) 100242. HTTPS://DOI.ORG/10.1016/J.SIPAS.2024.100242. (B)(6) HOSPITAL. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ARTICLE TITLED, ¿PREOPERATIVE PULMONARY FUNCTION IS ASSOCIATED WITH LEFT VENTRICULAR ASSIST DEVICE OUTCOMES¿, WAS RECEIVED. THE STUDY CONCLUDED THAT PREOPERATIVE PULMONARY FUNCTION WAS ASSOCIATED WITH SHORT-TERM LVAD SURVIVAL, POSTOPERATIVE VENTILATORY TIME, AND NEED FOR TRACHEOSTOMY. THE DEVICE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    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. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿PREOPERATIVE PULMONARY FUNCTION IS ASSOCIATED WITH LEFT VENTRICULAR ASSIST DEVICE OUTCOMES¿ IDENTIFYING THAT HM3 MAY BE RELATED TO INCREASE OF VENTILATION REQUIREMENT, INCREASE OF PULMONARY DYSFUNCTION AND DEATH IN PATIENT WITH PRE-DIAGNOSED PULMONARY DYSFUNCTION THAT WERE IMPLANTED WITH HM3. THIS WAS A RETROSPECTIVE OBSERVATIONAL STUDY WHICH INCLUDED ALL HM3 IMPLANTS (N=107) FROM 2017 THROUGH 2022. THE AIM OF THIS STUDY WAS TO BETTER UNDERSTAND THE RELATIONSHIP BETWEEN PRE-EXISTING PULMONARY DYSFUNCTION AND SURVIVAL AFTER LVAD IMPLANTATION. OVERALL, 30-DAY AND 1-YEAR SURVIVAL WERE 98.10 % AND 86.83 % RESPECTIVELY. WHEN STRATIFIED BY TYPE OF PREOPERATIVE PULMONARY SUPPORT, PATIENTS ON ROOM AIR OR REQUIRING ONLY NASAL CANNULA SUPPORT HAD IMPROVED SURVIVAL COMPARED TO THOSE REQUIRING NONINVASIVE OR INVASIVE POSITIVE PRESSURE VENTILATION AT 1-YEAR. THE MEDIAN OVERALL POSTOPERATIVE MECHANICAL VENTILATORY TIME WAS 20.38H OR 0.8 DAYS. A TOTAL OF 18 (16.82 %) PATIENTS REQUIRED POSTOPERATIVE TRACHEOSTOMY WHICH WAS PERFORMED A MEDIAN OF 7 [4¿9] DAYS AFTER SURGERY. INCREASINGLY INTENSIVE PREOPERATIVE METHODS OF PULMONARY SUPPORT WERE ASSOCIATED WITH AN INCREASE IN POSTOPERATIVE MECHANICAL VENTILATION TIME AND WITH AN INCREASED NEED FOR POSTOPERATIVE TRACHEOSTOMY. BECAUSE OF THE COMPLEXITY OF ASSESSING PREOPERATIVE PULMONARY FUNCTION, THE ANALYSIS WAS STRATIFIED IN DIFFERENT WAYS. FIRST, WHEN STRATIFIED BY THE TYPE OF PREOPERATIVE PULMONARY SUPPORT, IT WAS FOUND THAT PATIENTS ON ROOM AIR OR ONLY NASAL CANNULA HAD SIGNIFICANTLY IMPROVED SHORT-TERM SURVIVAL COMPARED TO THOSE REQUIRING MORE INVASIVE MODES OF VENTILATION. SECOND, PATIENTS WERE STRATIFIED BASED ON PRE-OPERATIVE LEVEL OF FIO2 REQUIRED. INCREASING FIO2 WAS STRONGLY ASSOCIATED WITH SHORT-TERM MORTALITY. THIRD, PATIENTS STRATIFIED BY PFT VALUES, SPECIFICALLY FEV1, THE LOWEST TERTILE OF FEV1 WAS STRONGLY ASSOCIATED WITH 1-YEAR MORTALITY ON BOTH UNIVARIATE AND MULTIVARIABLE ANALYSIS. ALTHOUGH FEV1 SEEMED TO HAVE THE STRONGEST DISCRIMINATORY POWER, IT IS ALSO THE HARDEST TO OBTAIN AS MANY HOSPITALIZED PATIENTS ARE TOO UNSTABLE FOR FORMAL PFT TESTING OR EVEN BEDSIDE SPIROMETRY. THESE RESULTS SUGGEST THAT INCREASED PREOPERATIVE PULMONARY DYSFUNCTION ¿ WHETHER DETERMINED BY ABSOLUTE FIO2, MODE OF PREOPERATIVE VENTILATORY SUPPORT, OR FORMAL FEV1 ASSESSMENT ¿ IS STRONGLY ASSOCIATED WITH SHORT-TERM MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540453 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R