BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 16966812 · Received May 19, 2023

    Report

    Report Number
    3007042319-2023-02247
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    July 1, 2021
    Report Date
    May 19, 2023
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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 WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: BIVENTRICULAR SUPPORT USING PROTEKDUO CANNULA IN A CHILD. AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS ASAIO JOURNAL 2021; 67(7):E124¿E126. PMID: (B)(6) DOI: (B)(6). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING BIVENTRICULAR VENTRICULAR ASSIST DEVICE (BIVAD) SUPPORT IN A CHILD. THE AUTHORS DESCRIBED A PATIENT WHO DEVELOPED RIGHT HEART FAILURE WITH GRADUAL ELEVATION OF RIGHT ATRIAL PRESSURE AND RENAL DYSFUNCTION APPROXIMATELY TWO DAYS POST IMPLANT OF THE LEFT VAD. THIS OCCURRED DESPITE REINSTITUTION OF INOTROPIC INFUSIONS, NITRIC OXIDE DELIVERY VIA NASAL CANNULA AND FLUID REMOVAL WITH CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). TWENTY DAYS LATER, THE PATIENT WAS PUT ON RIGHT VAD (RVAD) SUPPORT WITH A CANNULA PERCUTANEOUSLY PLACED IN THE RIGHT INTERNAL JUGULAR (RIJ) VEIN AND CONNECTED TO AN RVAD. FOUR DAYS LATER, THE PATIENT DEVELOPED OROPHARYNGEAL BLEEDING AND THE CANNULA CLOTTED AND WAS REMOVED. RENAL FUNCTION WORSENED AND NINE DAYS AFTER THE CANNULA WAS REMOVED, THE RVAD SUPPORT WAS REINITIATED WITH A DIFFERENT CANNULA. THE PATIENT'S END-ORGAN FUNCTION IMPROVED AND THEY UNDERWENT A SUCCESSFUL HEART TRANSPLANT. THE STATUS OF THE LEFT VAD IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479309 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention| L