BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 18587617 · Received January 26, 2024

    Report

    Report Number
    3007042319-2024-00283
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 18, 2024
    Report Date
    April 2, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707003261
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. NO PERFORMANCE ALLEGATIONS WERE MADE AGAINST THE DEVICE; THEREFORE, THE PURPOSE OF THIS INVESTIGATION IS SOLELY TO ADDRESS THE FINDING IDENTIFIED DURING ANALYSIS OF THE CONTROLLER LOG FILES. REVIEW OF THE LOG FILES AND MOTOR START REPORT REVEALED MOTOR START EVENTS RECORDED ON 31/JUL/2020, 01/JUN/2021, 02/JUN/2021, 03/JUN/2021, 08/JUN/2021, 23/SEP/2021, 24/SEP/2021, 22/APR/2022, 30/JUN/2022, 01/JUL/2022, 26/AUG/2022, 07/SEP/2022, 28/OCT/2022, 31/OCT/2022, 18/NOV/2022, 06/DEC/2022, 20/APR/2023, 26/APR/2023, 25/MAY/2023, 22/JUN/2023, 03/AUG/2023, AND 04/AUG/2023 IN WHICH THE MOTOR START PARAMETER(S) WERE ATYPICAL. AS A RESULT, THE FINDING WAS CONFIRMED. BASED ON A HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF ATYPICAL MOTOR START PARAMETERS MAY BE ATTRIBUTED, BUT NOT LIMITED, TO OUTER SHROUD CONTACT THAT CREATES MORE FRICTION AT THE HOUSING TO IMPELLER INTERFACE DURING PUMP STARTUP. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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

    RETROSPECTIVE DATA FILE REVIEW CONDUCTED ON 18-JAN-2024 REVEALED MULTIPLE MOTOR START EVENTS WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE. THIS VENTRICULAR ASSIST DEVICE (VAD) IS NOT IN A SUBGROUP POPULATION FOR DELAY OR FAILURE TO RESTART. THE CLINICIAN WAS NOTIFIED OF THE MOTOR START HISTORY AND THE VAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016697 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707003261

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male D334VRG ICD & 694758 LEAD.