BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 12225140 · Received July 26, 2021

    Report

    Report Number
    3007042319-2021-05457
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 15, 2021
    Report Date
    September 20, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707005364
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED A SUDDEN DECREASE IN POWER CONSUMPTION TO PARAMETERS BELOW THE NORMAL OPERATING RANGE ON (B)(6) 2021; 115 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2021. INFORMATION RECEIVED INDICATED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED ONGOING LOW FLOW ALARMS AND THE PATIENT WAS ADMITTED FOR A SUSPECTED THROMBUS. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING, BUT NOT LIMITED, TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. PER THE INSTRUCTIONS FOR USE, THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF SIMILAR ADVERSE EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING ANY INTERVENTIONS PERFORMED AND ADDITIONAL PATIENT DETAILS, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED ONGOING LOW FLOW ALARMS AND THE PATIENT WAS ADMITTED FOR A SUSPECTED THROMBUS. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122122 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. MCS1705PU 00888707005364

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| L