BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 21002248 · Received December 23, 2024

    Report

    Report Number
    3007042319-2024-05269
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    June 21, 2022
    Report Date
    December 23, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. 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: CHEST COMPRESSIONS IN PEDIATRIC PATIENTS WITH CONTINUOUS-FLOW VENTRICULAR ASSIST DEVICES: CASE SERIES AND PROPOSED ALGORITHM. FRONTIERS IN PEDIATRICS. 2022. VOLUME 10; ARTICLE 883320. DOI: 10.3389/FPED.2022.883320 D4: UDI INFORMATION IS UNABLE TO BE OBTAINED AS THE NECESSARY INFORMATION IS UNAVAILABLE 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 CHEST COMPRESSIONS IN PEDIATRIC PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (VAD). THE AUTHORS DESCRIBED ONE PATIENT, APPROXIMATELY FOURTEEN DAYS POST IMPLANT, WHOSE VAD EXHIBITED AN ACUTE DROP IN FLOWS, MEAN ARTERIAL PRESSURE(MAP) DROPPED, AND THEY BECAME SUDDENLY UNRESPONSIVE. CHEST COMPRESSIONS WERE INITIATED DUE TO THEIR ALTERED MENTAL STATUS, IMMEDIATELY FOLLOWED BY THE ADMINISTRATION OF AN EPINEPHRINE DOSE AND AN INTRAVENOUS FLUID BOLUS. AFTER TWO MINUTES OF CARDIOPULMONARY RESUSCITATION VAD FLOWS INCREASED AND MAP NORMALIZED. THEY WERE SUBSEQUENTLY CONFIRMED TO HAVE PERICARDIAL TAMPONADE AND UNDERWENT MEDIASTINAL EXPLORATION WITH HEMATOMA EVACUATION. ON POST-OPERATIVE DAY 24, THE PATIENT HAD ANOTHER ACUTE DROP IN VAD FLOW AFTER ADMINISTRATION OF A FOSPHENYTOIN DOSE FOR NEW-ONSET SEIZURES. VAD FLOWS AGAIN DROPPED, AND MAP DROPPED. THEY WERE GIVEN A DOSE OF EPINEPHRINE AND AN INTRAVENOUS FLUID BOLUS. VAD FLOWS AND MAP NORMALIZED. THE DEVICE REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623695 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention| L