BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 8681100 · Received June 7, 2019

    Report

    Report Number
    3007042319-2019-07233
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 5, 2019
    Report Date
    July 15, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH REVEALED A DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW STARTING ON 03-MAY-2019, FOLLOWED BY AN INCREASE IN POWER CONSUMPTION STARTING ON 11-MAY-2019 LEADING TO PARAMETERS ABOVE NORMAL OPERATING RANGE. THREE LOW FLOW ALARMS WERE LOGGED ON (B)(6) 2019 AND 81 HIGH WATT ALARMS HAVE BEEN LOGGED SINCE 13-MAY-2019. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE ROOT CAUSES OF THE 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 VAD ROTATIONAL SPEED. BASED ON HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. 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. 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

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUSPECTED PUMP THROMBUS DUE TO THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITING HIGH AND LOW FLOWS, AND ABOVE NORMAL POWER CONSUMPTION. THE PATIENT RECEIVED A THROMBOLYTIC AND 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
    473371 HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R