BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22342896 · Received June 26, 2025

    Report

    Report Number
    2916596-2025-04004
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 11, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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 JANUARY 2022 AND MARCH 2025. AUTHOR CITATION: SCHNEGG, B., DEVEZA, R., BARUA, S., SANJAY CHAVALI, LO, P., CAPEK, L., BRUNO, J., PAVLICEK-BAHLO, M., XOURGIA, E., NEAGOE, A., ZÜRCHER, K., KAVITHA MUTHIAH, LAM, K., REINEKE, D., MATTHIAS SIEPE, HUNZIKER, L., MARTINELLI, M., MACDONALD, P., & HAYWARD, C. (2025). LOW DOSE APIXABAN IN HEARTMATE 3 LVAD PATIENTS, INTERIM ANALYSIS OF THE APIXIVAD TRIAL, A RANDOMIZED CONTROLLED STUDY. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION. HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.04.012. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED 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, REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. B ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS THE ADVERSE EVENTS, INCLUDING BLEEDING, DEVICE THROMBUS, STROKE, AND SEPSIS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ADDITIONALLY, THIS SECTION, UNDER ¿ANTICOAGULATION¿, PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. ALTHOUGH ONLY SEPSIS WAS REPORTED BY THE ACCOUNT, THE IFU ALSO LISTS INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, AS WELL AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ADDITIONALLY, SEVERAL SECTIONS OF THE HM3 LVAS IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS 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 ¿LOW DOSE APIXABAN IN HEARTMATE 3 LVAD PATIENTS, INTERIM ANALYSIS OF THE APIXIVAD TRIAL, A RANDOMIZED CONTROLLED STUDY¿ THAT HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE ASSOCIATED WITH BLEEDING, THROMBOEMBOLIC EVENTS, ISCHEMIC AND HEMORRHAGIC STROKE, SEPTIC SHOCK, AND DEATH. THE APIXIVAD TRIAL WAS LAUNCHED TO TEST THE FEASIBILITY AND SAFETY OF LOW-DOSE APIXABAN IN STABLE HM3 PATIENTS, WITH A FOLLOW-UP OF UP TO 24 MONTHS OR UNTIL TRANSPLANTATION. THE APIXIVAD STUDY IS AN INVESTIGATOR-INITIATED, RANDOMIZED, CONTROLLED, OPEN-LABEL PILOT TRIAL CONDUCTED AT TWO INTERNATIONAL CENTERS. IT AIMS TO EVALUATE THE SAFETY OF LOW-DOSE APIXABAN (2.5 MG TWICE DAILY) COMPARED TO STANDARD VITAMIN K ANTAGONIST (VKA) THERAPY IN PATIENTS WITH HM3. A TOTAL OF 50 PATIENTS WERE TARGETED FOR ENROLLMENT OVER THREE YEARS. THE PRIMARY ENDPOINT WAS A COMPOSITE OF DEATH (1 PATIENT), PUMP THROMBOSIS/THROMBOEMBOLIC EVENTS, STROKES (1 PATIENT), AND MAJOR BLEEDING (3 PATIENTS), WITH TREATMENT CONTINUING UNTIL HEART TRANSPLANTATION OR A MAXIMUM OF 24 MONTHS. THE APIXIVAD INTERIM ANALYSIS EVALUATED THE SAFETY OF LOW-DOSE APIXABAN VERSUS STANDARD VITAMIN K ANTAGONIST (VKA) THERAPY IN PATIENTS WITH HM3. BETWEEN JANUARY 2022 AND MARCH 2025, 44 PATIENTS WERE ENROLLED¿21 RECEIVED APIXABAN AND 23 RECEIVED VKA. MOST PATIENTS (84%) WERE IMPLANTED AS A BRIDGE TO TRANSPLANT, AND THE MEDIAN TIME FROM LVAD IMPLANTATION TO RANDOMIZATION WAS SIX MONTHS. REGARDING HEMOCOMPATIBILITY-RELATED OUTCOMES, FIVE PATIENTS EXPERIENCED A PRIMARY EVENT: THREE HEMORRHAGIC EVENTS (TWO IN THE APIXABAN GROUP AND ONE IN THE VKA GROUP), ALL OF WHOM WERE ALSO ON ASPIRIN. ONE VKA PATIENT HAD A MINOR STROKE, AND ONE APIXABAN PATIENT DIED FROM PNEUMONIA AND SEPTIC SHOCK AFTER CHOOSING PALLIATIVE CARE. THE RATE OF HEMOCOMPATIBILITY-RELATED EVENTS WAS NEARLY IDENTICAL BETWEEN GROUPS¿16.9 PER 100 PATIENT-YEARS FOR APIXABAN AND 16.4 FOR VKA. THE ABSOLUTE DIFFERENCE IN EVENT RATES WAS 5.3%, WHICH WAS NOT STATISTICALLY SIGNIFICANT AND REMAINED BELOW THE PREDEFINED THRESHOLD FOR CONCERN. FOURTEEN PATIENTS REMAINED ON ACTIVE TREATMENT AT THE TIME OF THIS ANALYSIS. THE INTERIM RESULTS OF THE APIXIVAD STUDY SUGGEST THAT USING A REDUCED DOSE OF APIXABAN (2.5 MG TWICE DAILY) IN PATIENTS WITH HM3 IS PROMISING. THIS DOSAGE APPEARED TO PROVIDE ADEQUATE ANTICOAGULATION IN THE SHORT TO MEDIUM TERM AND DID NOT LEAD TO INCREASED BLEEDING DURING HEART TRANSPLANTATION WHEN MANAGED UNDER CURRENT CLINICAL PROTOCOLS. HOWEVER, DUE TO THE STUDY¿S SMALL SAMPLE SIZE, THESE FINDINGS ARE CONSIDERED PRELIMINARY AND SHOULD BE VIEWED AS HYPOTHESIS-GENERATING RATHER THAN DEFINITIVE. FURTHER RESEARCH WITH LARGER COHORTS IS NEEDED TO CONFIRM THESE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972866 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R