BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 20050204 · Received August 23, 2024

    Report

    Report Number
    3007042319-2024-04402
    Event Type
    Death
    Date Received
    August 23, 2024
    Date of Event
    August 12, 2024
    Report Date
    December 2, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707006323
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 2.0 D4: MODEL #:  1420/ CATALOG #:1420/ EXPIRATION DATE:31-OCT-2022 /SERIAL OR LOT#:  (B)(6) UDI #: (B)(4). D9: NO H3: NO H4: MFG DATE: 20-OCT-2021 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 2.0 D4: MODEL #:  1420/ CATALOG #:1420/ EXPIRATION DATE:30-APR-2023 /SERIAL OR LOT#:  (B)(6) UDI #: (B)(4). D9: NO H3: NO H4: MFG DATE: 08-APRIL-2022 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650/  EXPIRATION DATE: 31-MAR-2024 / SERIAL OR LOT#: (B)(6) UDI #: (B)(4) D9: NO H3: NO H4: MFG DATE:  02-MAR-2023 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650/  EXPIRATION DATE: 30-APR-2024 / SERIAL OR LOT#: (B)(6) UDI #: (B)(4) D9: NO H3: NO H4: MFG DATE:  04-APR-2023 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION SUMMARY. ADDITIONAL PRODUCT: SERIAL# (B)(6) H3: YES SERIAL# (B)(6) H3: YES SERIAL# (B)(6) H3: YES SERIAL# (B)(6) H3: YES H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) ((B)(6)), TWO (2) CONTROLLERS ((B)(6) AND TWO (2) BATTERIES ((B)(6) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED THAT (B)(6) WAS THE PATIENT¿S PRIMARY CONTROLLER, IN USE AT THE TIME OF THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED A DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS TO PARAMETERS BELOW NORMAL OPERATING RANGE STARTING ON (B)(6) 2024 AND ONE (1) LOW FLOW ALARM LOGGED ON (B)(6) 2024 AT 01:15:21. REVIEW OF THE ALARM LOG FILE REVEALED ONE (1) CRITICAL BATTERY ALARM INVOLVING (B)(6) LOGGED ON (B)(6) 2024 AT 10:45:15. THE CRITICAL BATTERY ALARM IS THE RESULT OF THE BATTERY DEPLETING BELOW 10% RELATIVE STATE OF CHARGE (RSOC). ANALYSIS OF THE LOG FILES REVEALED THAT, AT THE TIME OF THE ALARM, (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 24% RSOC AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 9% RSOC. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED THAT (B)(6) WAS MOST LIKELY THE PATIENT¿S BACKUP CONTROLLER. LOG FILE ANALYSIS REVEALED THAT THIS CONTROLLER WAS NOT IN USE DURING THE REPORTED EVENT. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. OF NOTE, INFORMATION PROVIDED BY THE SITE INDICATED THAT ARRHYTHMIA MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE PATIENT¿S DEATH. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE 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. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARM EVENT CAN BE ATTRIBUTED TO THE BATTERY DEPLETING BELOW 10% RSOC. PER THE INSTRUCTIONS FOR USE, CARDIAC ARRHYTHMIA AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF CARDIAC ARRHYTHMIA 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT HAS EXPIRED. IT WAS STATED THAT "AN ARRHYTHMIA MAY HAVE BEEN A CONTRIBUTING FACTOR. THE PATIENT EXPERIENCED A LOW FLOW EVENT EARLY IN THE MORNING, BUT NO ALARMS WERE TRIGGERED UNTIL A CRITICAL BATTERY ALARM AROUND 10:30 AM, WHICH WAS HEARD BY NEIGHBORS WHO THEN ALERTED EMERGENCY SERVICES. THE PATIENT LIVED ALONE, SO THE EXACT CIRCUMSTANCES ARE UNCLEAR. ARRHYTHMIAS WERE NOTED AROUND 3:43 AM, BUT THERE'S A POSSIBLE TIME DISCREPANCY. WHEN PARAMEDICS RECONNECTED THE BATTERIES, THE CONTROLLER ALARMED FOR "LOW FLOW," THOUGH NO SUCH EVENTS WERE RECORDED IN THE DOWNLOAD. THE DRIVELINE WAS CUT, AND PART OF IT WAS DISCARDED." .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072393 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104 00888707006323

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death