BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 23184571 · Received September 30, 2025

    Report

    Report Number
    3007042319-2025-02085
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 30, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: SURVIVAL AND READMISSION BURDEN IN ADVANCED HEART FAILURE PATIENTS MANAGED WITH VENTRICULAR ASSIST DEVICE VERSUS CONTINUED MEDICAL THERAPY. ASAIO JOURNAL. 2025; 71:628¿636. DOI: 10.1097/MAT.0000000000002382 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 RISK¿BENEFIT OF LEFT VENTRICULAR ASSIST DEVICE (VAD) THERAPY VERSUS MEDICAL THERAPY IN ADVANCED HEART FAILURE PATIENTS. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DESCRIBED AS ALL-CAUSE MORTALITY. THERE WERE PATIENTS WHO WERE READMITTED TO THE HOSPITAL DUE TO MAJOR INFECTION WHICH INCLUDED CORONAVIRUS DISEASE 2019, MAJOR BLEEDING, RIGHT HEART FAILURE, ARRHYTHMIAS, NEUROLOGICAL DYSFUNCTION, UNKNOWN DEVICE MALFUNCTIONS, HYPERTENSION, PSYCHIATRIC EPISODES, HEMATOMA, HEMOLYSIS, HEPATIC DYSFUNCTION, VENOUS THROMBOEMBOLIC EVENT, RESPIRATORY FAILURE, SYNCOPE, RENAL DYSFUNCTION, FEVER, WOUND COMPLICATIONS, ANTICOAGULATION ADJUSTMENT, FLUID OVERLOAD, AND OTHER UNKNOWN REASONS. THE STATUS OF THE VADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215146 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization