BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JENAVALVE TECHNOLOGY, INC.

    MDR report key: 25225251 · Received May 19, 2026

    Report

    Report Number
    3012148004-2026-70004
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    JENAVALVE TECHNOLOGY, INC.
    Product Code
    NPT
    UDI-DI
    00850000898196
    PMA / PMN Number
    P250024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SOME OF THE PATIENT IDENTIFYING INFORMATION SUCH AS AGE, SEX, AND DATE OF BIRTH IS NOT RECEIVED BY JENAVALVE TECHNOLOGY, INC PER DSGVO REGULATIONS.

    Description of Event or Problem · 0

    A PATIENT-RELATED ADVERSE EVENT OCCURRED ON APRIL 21, 2026, DURING IMPLANTATION OF A TRILOGY-THV-M DEVICE IN (B)(6) IN GERMANY. DURING POSITIONING OF THE VALVE, THE PATIENT EXPERIENCED HEMODYNAMIC DECOMPENSATION. IN RESPONSE, A FEMORAL-FEMORAL BYPASS WAS INITIATED, RESULTING IN STABILIZATION OF THE PATIENT'S CONDITION. ALTHOUGH FEMORAL-FEMORAL BYPASS ACCESS WAS ESTABLISHED, THE BYPASS MACHINE WAS NOT ACTIVATED; IT REMAINED ON STANDBY AS A PRECAUTIONARY MEASURE. FULL CARDIOPULMONARY BYPASS SUPPORT WAS NOT REQUIRED. PATIENT AGE, SEX, WEIGHT AND RACE WERE NOT AVAILABLE AT THE TIME OF REPORTING. FOLLOWING HEMODYNAMIC RECOVERY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT REMAINED STABLE POST-PROCEDURE AND WAS WEANED WITHOUT DIFFICULTY. THE TRILOGY TRANSCATHETER HEART VALVE DEVICE IS WELL-POSITIONED AND FUNCTIONING AS INTENDED. ON APRIL 28, 2026, THE IMPLANTING PHYSICIAN REPORTED THAT THE PATIENT'S OVERALL RECOVERY HAS BEEN SATISFACTORY AND IS ACTIVELY RECOVERING. THE PHYSICIAN ALSO NOTED THAT THE AORTIC INSUFFICIENCY (AI) MAY HAVE BEEN EXACERBATED BY MANIPULATION OF THE WIRE AND/OR DEVICE OR SHEATH, POTENTIALLY CONTRIBUTING TO THE ACUTE DECOMPENSATION. HOWEVER, THE EXACT MECHANISM REMAINS UNCERTAIN, AND NO DEFINITIVE PREVENTIVE STRATEGY HAS BEEN IDENTIFIED. A POSSIBLE ALTERNATIVE APPROACH, SUCH AS INITIATING POSITIONING AT A HIGHER LEVEL, IS CONSIDERED SPECULATIVE. THE DEVICE WAS NOT RETURNED AS IT WAS DISPOSED PRIOR TO REQUEST. JENAVALVE TECHNOLOGY CONDUCTED A FULL DHR REVIEW WHICH SHOWED THAT ALL COMPONENTS OF THE SYSTEM PASSED ALL INSPECTION. BASED ON THE PROVIDED INFORMATION, ALTHOUGH THIS EVENT IS ATTRIBUTED TO THE PROCEDURE, IT IS NOT SUSPECTED THAT A DEVICE DEFICIENCY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38618 JENAVALVE TECHNOLOGY, INC. N/A NPT JENAVALVE TECHNOLOGY, INC. TRILOGY-INT DS-120825-003 00850000898196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention