BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25145155 · Received May 11, 2026

    Report

    Report Number
    2916596-2026-2916614
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    August 1, 2024
    Report Date
    May 11, 2026
    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
    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 ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01AUG2024, SINCE THE DATE OF DATA COLLECTION OCCURRED BETWEEN AUGUST 2018 AND AUGUST 2024. A. BILIC, ET AL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION 44 (2025) 44(4): S181-182. DOI:10.1016/J.HEALUN.2025.02.359 CARDIOVASCULAR MEDICINE, INTERMOUNTAIN MEDICAL CENTER, MURRAY, UT. 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 ¿PREVENTING EXTRINSIC OUTFLOW GRAFT OBSTRUCTION IN LEFT VENTRICULAR ASSIST DEVICE¿ IDENTIFYING THAT THE HEARTMATE 3 (HM3) WAS ASSOCIATED WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO) AND URGENT TRANSPLANT. THIS STUDY EVALUATED THE IMPACT OF EOGO ON CLINICAL OUTCOMES AND THE ROLE OF BEND RELIEF (BR) FENESTRATION AT THE TIME OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) SURGERY IN PREVENTING EOGO. THIS WAS A RETROSPECTIVE STUDY OF 55 ADULT PATIENTS (PTS) WHO UNDERWENT HM3 LVAD IMPLANTATION BETWEEN AUGUST 2018 AND AUGUST 2024. STATISTICAL ANALYSIS COMPARED OUTCOMES BETWEEN LVAD PTS WITHOUT BEND RELIEF (BR) FENESTRATION (GROUP 1, N=24) AND WITH BR FENESTRATION (GROUP 2, N=31). EOGO WAS OBSERVED IN 13 PTS 58% OF GROUP 1 AFTER A MEDIAN SUPPORT DURATION OF 21 MONTHS. EOGO WAS CONFIRMED IN 8 PTS VIA EXPLANT PATHOLOGY REPORTS AND IN 6 THROUGH CARDIAC IMAGING. OF THE 14 PTS WITH EOGO, 7 WERE URGENTLY LISTED FOR TRANSPLANT, WHILE ONE DESTINATION THERAPY (DT) PT UNDERWENT CARDIAC IMAGING EVERY 3 MONTHS. CONVERSELY NO CASES OF EOGO WERE DETECTED IN GROUP 2 VIA CARDIAC IMAGING OR LVAD EXPLANT, RESULTING IN A 0% INCIDENCE. BR FENESTRATIONS EFFECTIVELY MITIGATED EOGO-RELATED COMPLICATIONS IN HM3 LVAD PTS AND REDUCED THE NEED FOR URGENT TRANSPLANT LISTINGS. THIS PREEMPTIVE STRATEGY OFFERS A PROMISING APPROACH TO PREVENT EOGO-RELATED COMPLICATIONS, ESPECIALLY IN DESTINATION THERAPY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208112 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1