BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 13943876 · Received March 29, 2022

    Report

    Report Number
    3007042319-2022-04492
    Event Type
    Death
    Date Received
    March 29, 2022
    Date of Event
    March 7, 2022
    Report Date
    June 2, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: (B)(4) WAS NOT RETURNED FOR EVALUATION. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES AND THE AVAILABLE AUTOLOGS REPORT, WHICH REVEALED A DECREASE IN POWER CONSUMPTION ON (B)(6) 2022 FOLLOWED BY A STEADY INCREASE IN POWER CONSUMPTION LEADING TO PARAMETERS ABOVE NORMAL OPERATING RANGE. A SHARP INCREASE IN POWER CONSUMPTION WAS THEN LOGGED ON (B)(6) 2022, FOLLOWED BY SHARP DECREASES TO BASELINE PARAMETERS. THREE (3) HIGH WATT ALARMS WERE LOGGED SINCE (B)(6) 2022. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT WAS ADMITTED FOR A SUSPECTED DEVICE THROMBUS. THE PATIENT ALSO HAD A POSSIBLE MYCOBACTERIAL INFECTION WHICH WAS BEING MANAGED ON AN OUTPATIENT BASIS PRIOR TO ADMISSION. THE PATIENT RECEIVED TISSUE PLASMINOGEN ACTIVATOR (TPA), AFTER WHICH THE PATIENT HAD A HEAD BLEED AND DIED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. THE INITIAL DECREASE IN POWER CONSUMPTION MAY BE ATTRIBUTED TO THROMBUS AT THE INFLOW CANNULA WHICH LIKELY GOT INGESTED INTO THE PUMP. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS, INFECTION, NEUROLOGICAL DYSFUNCTION, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF INFECTION 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL EVENT DETAILS. THE EVENT DESCRIPTION, THE RELEVANT HISTORY AND ANNEX E CODE HAS BEEN UPDATED. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. CONCOMITANT MEDICAL PRODUCTS: 359067 LEAD, IMPLANTED: (B)(6) 2015; UNKNOWN COMPETITOR ICD, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD CONTINUED WORK UPS FOR POSSIBLE MYCOBACTERIAL INFECTION WHICH WAS BEING MANAGED ON AN O UTPATIENT BASIS UNTIL THE PATIENT WAS CURRENTLY ADMITTED FOR THE MANAGEMENT OF SUSPECTED THROMBUS. IT WAS NOTED THAT THERE WERE THREE HIGH WATTS ALARM AND THAT THE HIGH WATT ALARM LIMIT WAS SET TO 10.0 WATTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A SUSPECTED VENTRICULAR ASSIST DEVICE (VAD) THROMBUS. THE PATIENT REPORTED THAT THERE WAS ELEVATED POWER AND FLOW ON THE VAD. IT WAS NOTED THAT NO VAD ALARMS HAD BEEN PRESENT AND THE HIGH WATT ALARM WAS SET AT 6.5. THE PATIENT¿S RETURN TO FLOW WAS 85. A FEW WEEKS BEFORE ADMISSION INTO THE HOSPITAL, THE POWER AND FLOW STARTED SLOWLY INCREASING. A FEW DAYS BEFORE ADMISSION, THE POWER AND FLOW BEGAN SHARPLY INCREASING. WHEN THE PATIENT CALLED FOR ADMISSION, THE WATTS WERE 6.2, AND FLOW WAS 7.0. UPON ADMISSION, THE WATTS WENT DOWN TO 5.9, AND FLOW WENT DOWN TO 6.6. A COUPLE OF DAYS LATER, THE PATIENT DIED AS A RESULT OF TREATING THE PUMP THROMBUS. THE PATIENT HAD A HEAD BLEED AFTER RECEIVING TISSUE PLASMINOGEN ACTIVATOR (TPA) AND THE VAD WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729429 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death 6937A-65 LEAD.