BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 21852191 · Received April 16, 2025

    Report

    Report Number
    3007042319-2025-00773
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    October 26, 2024
    Report Date
    April 16, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. 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/UNKNOWN. 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. REFERENCED ARTICLE: POOLED COMPARATIVE ANALYSIS OF TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE. GENERAL THORACIC AND CARDIOVASCULAR SURGERY. 2025. 73:125¿129. DOI: 10.1007/S11748-024-02100-3 D4: UDI INFORMATION IS UNABLE TO BE OBTAINED AS THE PRODUCT WAS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND D4 UDI IS THEREFORE BLANK. 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 TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (VAD). INDICATIONS FOR AORTIC VALVE REPLACEMENT INCLUDED WORSENING HEART FAILURE AND CARDIOGENIC SHOCK. THE AUTHORS DESCRIBED PATIENT DEATHS; THE CAUSES OF DEATH WERE PROGRESSION OF HEART FAILURE, PNEUMONIA, AND OTHER UNKNOWN CAUSES. THERE WERE PATIENTS WHO EXPERIENCED STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), MYOCARDIAL INFARCTION (MI), PACEMAKER IMPLANTATION, VASCULAR COMPLICATIONS, CARDIAC TAMPONADE, ACUTE KIDNEY INJURY (AKI), BLEEDING EVENTS WHICH REQUIRED TRANSFUSIONS, AND REINTERVENTIONS FOR UNKNOWN CAUSES. 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
    122750 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| L