BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22096925 · Received May 28, 2025

    Report

    Report Number
    2916596-2025-03033
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    January 1, 2023
    Report Date
    June 5, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. EISENGA, JOHN B; MCCULLOUGH, KYLE A; AFZAL, AASIM; DIMAIO, J MICHAEL; MOUBARAK, GHADI; ET AL. THE JOURNAL OF SURGICAL RESEARCH308: 202-208. (APR 2025)VENTRICULAR ASSIST DEVICE. THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 167(4), 1322¿1330.E6. HTTPS://DOI.ORG/10.1016/J.JTCVS.2022.09.051. (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTS OF DEVICE MALFUNCTION AND DEVICE ALARMS COULD NOT BE CONFIRMED BASED ON THE PROVIDED INFORMATION. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS DEVICE MALFUNCTION AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. 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. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. 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 ¿FACTORS ASSOCIATED WITH READMISSIONS FOLLOWING LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH HEART FAILURE EXASPERATION, MAJOR INFECTION, BLEEDING, UNEXPECTED SURGICAL/MEDICAL INTERVENTION, ARRHYTHMIA, NEUROLOGICAL DYSFUNCTION, KIDNEY DYSFUNCTION AND TRANSPLANT. THIS SINGLE-CENTER RETROSPECTIVE STUDY EVALUATED 151 PATIENTS WHO WERE IMPLANTED WITH A HM3 LEFT VENTRICULAR ASSIST DEVICE(LVAD) BETWEEN 2017 AND 2023 WHO WERE IMPLANTED WITH A DESTINATION THERAPY TREATMENT PLAN. THE AVERAGE AGE OF THE STUDY GROUP WAS 63.7 +/- 11.4 YEARS. 123 OF THE 151 PATIENTS WERE MALE. PATIENTS WHO RECEIVED A TRANSPLANT OR LVAD EXCHANGE AT ANY POINT FOR ANY REASON WERE EXCLUDED FROM THE STUDY THE GOAL OF THE STUDY WAS TO EVALUATE THE INCIDENCE AND FACTORS ASSOCIATED WITH READMISSION.12 PATIENTS WERE NOTED TO HAVE PASSED AWAY SHORTLY AFTER LVAD IMPLANT. 41 PATIENTS PASSED AWAY TOTAL. 38 PATIENTS HAD POSTOPERATIVE MAJOR BLEEDING, 6 PATIENTS HAD POSTOPERATIVE ISCHEMIC STROKE, 31 PATIENTS HAD POSTOPERATIVE RIGHT HEART FAILURE REQUIRING RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT, TEMPORARY HEMODIALYSIS WAS REQUIRED IN 23 PATIENTS POSTOPERATIVELY AND 27 PATIENTS REQUIRED A POSTOPERATIVE TRACHEOSTOMY. SOME OF THE PATIENTS WERE NOTED TO HAVE HAD TO BE ADMITTED TO THE INTENSIVE CARE UNIT (ICU) DUE TO THEIR POSTOPERATIVE COMPLICATIONS. THE 139 REMAINING PATIENTS EXPERIENCED 456 SEPARATE READMISSIONS WITH A MEDIAN FOLLOW-UP OF 590 (303-1002) DAYS AND A TOTAL FOLLOW-UP OF 270.7 PATIENT-YEARS FOR A RATE OF 1.7 READMISSIONS PER PATIENT YEAR. 108 OF THE PATIENTS HAD TO BE READMITTED AT LEAST ONE TIME. PATIENTS WERE READMITTED FOR HEART FAILURE EXACERBATION (27.0%), MAJOR INFECTION (17.8%) KIDNEY DYSFUNCTION (5.7%), CARDIAC ARRHYTHMIA (9.9%), PLANNED PROCEDURES(8.6%), NEUROLOGICAL DYSFUNCTION(4.8%) VARIOUS LVAD ALARMS/MALFUNCTIONS (3.7%), ANTICOAGULATION ADJUSTMENT (0.7%) OTHER UNKNOWN REASONS (8.3%), AND MAJOR BLEEDING (13.6%). PATIENTS WHO WERE READMITTED WITHIN 6 MONTHS WERE MORE LIKELY TO HAVE NEW YORK HEART ASSOCIATION CLASS III OR IV SYMPTOMS COMPARED TO THOSE WHO HAD NOT BEEN READMITTED 39.1% VERSUS 11.8% VERSUS 15%, P =0.0008. FOLLOWING LVAD IMPLANTATION, READMISSIONS WITHIN 6 MONTHS OF SURGERY ARE ASSOCIATED WITH WORSE FUNCTIONAL STATUS AT 6 MONTHS AND 1 YEAR POSTOPERATIVELY. INCREASED BODY MASS INDEX AND PREOPERATIVE BILIRUBIN WERE ASSOCIATED WITH MORE FREQUENT READMISSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328316 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown