BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    MDR report key: 8426429 · Received March 16, 2019

    Report

    Report Number
    3007042319-2019-05019
    Event Type
    Death
    Date Received
    March 16, 2019
    Date of Event
    February 19, 2019
    Report Date
    May 20, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: ONE PUMP WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. THE REPORTED HIGH-POWER EVENT COULD NOT BE CONFIRMED VIA REVIEW OF LOG FILES SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT PROVIDED FOR ANALYSIS. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE HIGH-POWER EVENT INCLUDING BUT NOT LIMITED TO THROMBUS FORMATION/INGESTION AND/OR HIGH FLOWS. 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. A VOLUNTARY MEDWATCH FORM 3500 WAS RECEIVED (REPORT #MW5084218); (B)(4). DATE USER FACILITY BECAME AWARE OF EVENT: DATE: (B)(6) 2019. TYPE OF REPORT: INITIAL. DATE OF THIS REPORT: 03/15/2019. APPROXIMATE AGE OF DEVICE: UNK. (B)(4). LOCATION WHERE EVENT OCCURRED: HOSPITAL. REPORT SENT TO MANUFACTURER: YES. MANUFACTURER NAME AND ADDRESS MFR. NAME: MEDTRONIC, PLC, (B)(4). 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 WAS ADMITTED TO THE HOSPITAL WITH A SUSPECTED PUMP THROMBUS. THE PUMP EXHIBITED HIGH POWER, ELEVATED FLOWS AND HIGH WATT ALARMS. THE PATIENT UNDERWENT THROMBOLYTIC THERAPY ON THREE OCCASIONS DURING HOSPITALIZATION, BUT PUMP THROMBI KEPT RECURRING. THE PATIENT RECEIVED CONTINUOUS INTRAVENOUS (IV) ANTICOAGULATION AND INOTROPE MEDICATIONS. THE PATIENT WAS NOT DEEMED A CANDIDATE FOR A PUMP EXCHANGE PROCEDURE AND RIGHT HEART CATHETERIZATION SHOWED PROFOUND RIGHT-SIDED HEART FAILURE AND ELEVATED LEFT-SIDED HEART PRESSURES WITH ADEQUATE CARDIAC OUTPUT. IT WAS NOTED THAT THE PUMP EXHIBITED UPTRENDING POWER CONSUMPTION AND FLOWS. THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219651 HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. UNK-PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death