BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 24500558 · Received March 3, 2026

    Report

    Report Number
    3007042319-2026-00439
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    January 1, 2025
    Report Date
    March 3, 2026
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TF-TAVI) FOR PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND AORTIC REGURGITATION. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. 2025. 106:3473¿3480. DOI: 10.1002/CCD.70213. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING AORTIC REGURGITATION (AR) IN PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (VAD). THE AUTHORS DESCRIBED A PATIENT WHO DEVELOPED SYMPTOMATIC SEVERE AR WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS IV SYMPTOMS THAT REQUIRED DIURESIS. THE PATIENT ALSO DEVELOPED DECOMPENSATED HEART FAILURE AND REQUIRED INOTROPIC AND INTENSIVE CARE UNIT (ICU) SUPPORT. TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TF-TAVI) WAS PERFORMED. TWO WEEKS LATER, THE PATIENT DEVELOPED SYMPTOMS OF RECURRENT FLUIDOVERLOAD AND WAS ADMITTED TO THE ICU FOR DIURESIS AND INOTROPIC SUPPORT. ECHOCARDIOGRAPHY REVEALED A SEVERE PARAVALVULAR LEAK AND DOWNWARD MIGRATION OF THE TRANSCATHETER HEART VALVE (THV). THE PATIENT SUCCESSFULLY UNDERWENT ANOTHER PROCEDURE WITH A DIFFERENT THV. THE VAD REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410698 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R