BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 15941845 · Received December 8, 2022

    Report

    Report Number
    3007042319-2022-08430
    Event Type
    Death
    Date Received
    December 8, 2022
    Date of Event
    December 5, 2022
    Report Date
    February 22, 2023
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿2.0 CONTROLLER, MODEL #: 1420/ CATALOG #: 1420, EXPIRATION DATE: 31-JAN-2019, SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 09-JAN-2018, LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿2.0 CONTROLLER, MODEL #: 1420 / CATALOG #: 1420, EXPIRATION DATE: 28-FEB-2022, SERIAL OR LOT#: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 18-DEC-2021, LABELED FOR SINGLE USE: NO. (B)(4). 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 · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE ANALYSIS. PRODUCT EVENT SUMMARY: THE PUMP (B)(6) AND TWO (2) CONTROLLERS (B)(6) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PATIENT'S PRIMARY CONTROLLER, INITIALLY IN USE DURING THE REPORTED EVENT. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) REVEALED A SHARP SUDDEN DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS LEADING TO PARAMETERS BELOW THE NORMAL OPERATING RANGE ON 5-DEC-2022 AND FIVE (5) LOW FLOW ALARMS WERE LOGGED ON 05-DEC-2022 STARTING AT 12:12:13. IN ADDITION, REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) REVEALED A VAD DISCONNECT ALARM WAS LOGGED ON 5-DEC-2022 AT 12:42:19 INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. OF NOTE, THE DRIVELINE WAS RECONNECTED AT 12:42:57 AFTER WHICH A SUCCESSFUL PUMP START EVENT WAS LOGGED AT 12:43:07. A SECOND VAD DISCONNECT ALARM WAS THEN LOGGED AT 12:47:08, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO THE REPORTED CONTROLLER EXCHANGE. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) REVEALED A TWO (2) CONTROLLER POWER UP EVENTS ON 05-DEC-2022 AT 12:51:47 AND 12:56:59 WITH AN ASSOCIATED SUCCESSFUL PUMP START EVENT AT 12:57:01. ADDITIONALLY, REVIEW OF THE DATA LOG FILE ASSOCIATED WITH (B)(6) REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE CONTROLLER POWER UP EVENTS; THE FIRST DATA POINT WAS LOGGED ON 05-DEC-2022 AT 12:52:22, INDICATING THAT THE POWER UP EVENTS OCCURRED DURING THE REPORTED CONTROLLER EXCHANGE. REVIEW OF THE ALARM LOG FILE ASSOCIATED WITH (B)(6) THEN REVEALED A VAD DISCONNECT ALARM LOGGED ON 5-DEC-2022 AT 12:51:54, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. IN ADDITION, (B)(6) LOG FILES REVEALED POWER CONSUMPTION BELOW THE NORMAL OPERATING RANGE ON 05-DEC-2022 AND ONE (1) LOW FLOW ALARM LOGGED ON 05-DEC-2022 AT 12:57:06. LOG FILES DID NOT REVEAL ANY VAD STOPPED ALARMS OR FAILURE TO RESTART EVENTS LOGGED WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED LOW FLOWS, VAD DISCONNECTS, AND CONTROLLER EXCHANGE EVENTS WERE CONFIRMED. HOWEVER, THE REPORTED VAD FAILED TO RESTART EVENT COULD NOT BE CONFIRMED. 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 CAUSES OF THE CONTROLLER POWER UP EVENTS INVOLVING (B)(6) CAN BE ATTRIBUTED TO THE REPORTED CONTROLLER EXCHANGE. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO PHYSICAL DISCONNECTIONS OF THE DRIVELINE FROM THE CONTROLLER. BASED ON THE RISK DOCUMENTATION, POSSIBLE 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, AND/OR POOR VAD FILLING. PER THE INSTRUCTIONS FOR USE, DEATH IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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. D4: SERIAL OR LOT#: (B)(6) D9: YES, RETURN DATE: 08-FEB-2023 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C23 H6: FDA CONCLUSION CODE(S): D11 D4: SERIAL OR LOT#: (B)(6) D9: YES, RETURN DATE: 08-FEB-2023 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) BEGAN EXHIBITING LOW FLOWS. THE DRIVELINE WAS DISCONNECTED THEN RECONNECTED TO THE SAME CONTROLLER. LATER, THE DRIVELINE WAS RECONNECTED TO A DIFFERENT CONTROLLER. THE PATIENT HAD EXCHANGED THE CONTROLLER AT HOME. IT WAS STATED THAT THE VAD HAD FAILED TO RESTART BUT IT WAS NOTED THAT LOG FILE REVIEW INDICATED THAT THE MOTOR RESTARTED EACH TIME THE DRIVELINE WAS RECONNECTED. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210971 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death 5076-45 LEAD, 6935M55 LEAD, DDMB1D4 ICD