BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 21842876 · Received April 15, 2025

    Report

    Report Number
    3007042319-2025-00766
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    January 1, 2023
    Report Date
    April 15, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: IMPELLA 5.5 IMPLANTATION IN A PATIENT WITH LEFT VENTRICULAR ASSIST DEVICE THROMBOSIS AS A BRIDGE TO RECOVERY STRATEGY. ARTIFICIAL ORGANS. 2023; 47:1898¿1899. DOI: 10.1111/AOR.14654 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 VENTRICULAR ASSIST DEVICE (VAD) THROMBOSIS. THE AUTHORS DESCRIBED A PATIENT WHO EXPERIENCED A PUMP THROMBOSIS APPROXIMATELY TWO YEARS POST IMPLANT. THE VAD WAS EXCHANGED. SEVERAL YEARS LATER, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ELEVATED POWER, LOW FLOW ALARMS, AND HEMOLYSIS AND HEMATURIA. COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAPHY REVEALED A RECURRENT SEVERE PUMP THROMBOSIS. THE VAD WAS DECOMMISSIONED VIA SLOW WEANING OF THE PUMP AND LIGATION OF THE OUTFLOW GRAFT. A TEMPORARY VAD WAS PLACED, REMOVED NINE DAYS LATER, AND SUBSEQUENTLY THE PATIENT EXPERIENCED CARDIAC RECOVERY. THE STATUS OF THE VAD IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116557 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening| H| R