BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 23350090 · Received October 21, 2025

    Report

    Report Number
    3007042319-2025-02160
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 21, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/57 YEARS OLD. 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: THE IMPACT OF PREOPERATIVE RIGHT VENTRICULAR DYSFUNCTION AND VENTRICULAR ARRHYTHMIAS ON LEFT VENTRICULAR ASSIST DEVICE OUTCOMES. ASAIO JOURNAL. 2025. 71:736¿743. DOI: 10.1097/MAT.000000000000240. 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 THE IMPACT OF PREOPERATIVE ECHOCARDIOGRAPHIC RIGHT VENTRICULAR (RV) DYSFUNCTION IN PATIENTS WITH VARYING DEGREES OF VENTRICULAR ARRHYTHMIAS UNDERGOING VENTRICULAR ASSIST DEVICE (VAD) IMPLANTATION. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DESCRIBED AS ALL-CAUSE OR IN-HOSPITAL MORTALITY. THERE WERE PATIENTS WHO EXPERIENCED POSTOPERATIVE SEVERE RV FAILURE, THE NEED FOR INOTROPES FOR MORE THAN FOURTEEN DAYS, THE NEED OF A RIGHT VAD OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), OR RENAL REPLACEMENT THERAPY. THERE WERE PATIENTS WHO UNDERWENT REHOSPITALIZATIONS AND PUMP EXCHANGES FOR UNKNOWN REASONS, AND OTHER PATIENTS THAT HAD ARRHYTHMIAS WITH SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE STATUS OF THE VADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817373 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| L| R