BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 24433301 · Received February 24, 2026

    Report

    Report Number
    3007042319-2026-00397
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    November 13, 2025
    Report Date
    February 24, 2026
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 HAS BEEN MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: BRIDGE TO HEART TRANSPLANTATION WITH NEARLY 800-DAY INTRACORPOREAL BIVENTRICULAR ASSISTANCE IN A PEDIATRIC PATIENT WITH DANON DISEASE: A CASE REPORT. JOURNAL OF ARTIFICIAL ORGANS (2026) 29:4 DOI: 10.1007/S10047-025-01534-7. 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 A PATIENT IMPLANTED WITH A VENTRICULAR ASSIST DEVICE (VAD) THAT EXPERIENCED SEVERE RIGHT VENTRICULAR FAILURE AND SUBSEQUENTLY UNDERWENT IMPLANTATION OF A RIGHT VAD. THE AUTHORS DESCRIBED THAT THE PATIENT EXPERIENCED A TRACHEOSTOMY, ABDOMINAL PAIN, NAUSEA, SEVERE AORTIC VALVE REGURGITATION AND PULMONARY VALVE REGURGITATION CONFIRMED BY ECHOCARDIOGRAM WHICH REQUIRED CLOSURE ON BOTH VALVES, AND A DRIVELINE INFECTION REQUIRING MULTIPLE HOSPITALIZATIONS. THE PATIENT RECEIVED A HEART TRANSPLANT.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486554 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R