BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 19630020 · Received June 27, 2024

    Report

    Report Number
    3007042319-2024-03795
    Event Type
    Death
    Date Received
    June 27, 2024
    Date of Event
    June 22, 2024
    Report Date
    March 13, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707003261
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1336-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ANALYSIS AND INVESTIGATION COMPLETION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM-SERIAL OR LOT#: (B)(6) H3: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM-SERIAL OR LOT#: (B)(6) H3: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM-SERIAL OR LOT#: (B)(6) H3: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM-SERIAL OR LOT#: (B)(6) H3: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. PRODUCT EVENT SUMMARY: ONE (1) PUMP (B)(6) AND FOUR (4) CONTROLLERS (B)(6) WERE RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED PUMP MET ALL REQUIREMENTS FOR RELEASE. A REVIEW OF THE CONTROLLERS¿ MANUFACTURING DOCUMENTATION WAS NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL EXAMINATION REVEALED ABRASIONS ON THE LOWER HOUSING CERAMIC SURFACE AND ON THE INFERIOR SURFACE OF THE IMPELLER. THESE FRICTION MARKS ARE INDICATIVE THAT AN EXTERNAL FACTOR MAY HAVE FORCED THE IMPELLER AGAINST THE REAR HOUSING WITH SUFFICIENT STRENGTH TO OVERCOME THE REAR PRELOAD OF THE MAGNETIC SPRING/SUSPENSION SYSTEM, THUS LEADING TO SCORING MARKS OBSERVED DURING VISUAL INSPECTION. DIMENSIONAL VERIFICATION REVEALED THAT THE FRONT AND REAR HOUSING DISC CURVATURES WERE FOUND TO BE DEVIATING FROM SPECIFICATIONS. CAPA PR00578223 WAS OPENED TO INVESTIGATE POST-EXPLANT ISSUES FOUND DURING FAILURE ANALYSIS OF RETURNED PUMPS. BIOLOGICAL MATERIAL WAS OBSERVED UPON OPENING OF THE RETURNED PUMP; HOWEVER, THE SAMPLE COULD NOT BE RETRIEVED FOR PATHOLOGICAL EVALUATION SINCE IT WAS FALLING APART. FAILURE ANALYSIS OF THE RETURNED CONTROLLERS REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING. FAILURE ANALYSIS REVEALED THAT (B)(6) PASSED EXTERNAL AND INTERNAL VISUAL INSPECTION. INTERNAL INSPECTION OF (B)(6) REVEALED A CRACK ON STANDOFF POST ONE (1) AND FIVE (5) AND AN INTERNAL INSPECTION OF (B)(6) REVEALED A CRACK ON STANDOFF POST ONE (1) WITHIN THE CONTROLLERS' HOUSINGS. THESE OBSERVED CRACKS ARE ADDITIONAL FINDINGS, NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION, THE ROOT CAUSE OF THE STANDOFF POST CRACK WAS DETERMINED TO BE DUE TO MINERAL OIL APPLIED TO THE CONTROLLER¿S INTERNAL MAIN GASKET AND/OR TO THE SILICONE ADHESIVE APPLIED AROUND THE CONTROLLER¿S INTERNAL BATTERY COMING INTO CONTACT WITH THE STANDOFF POST. THE MINERAL OIL AND/OR SILICONE ADHESIVE CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. CAPA PR00517125 IS INVESTIGATING THIS ISSUE. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PRIMARY CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(6) WAS THE INITIAL BACKUP CONTROLLER, (B)(6) WAS THE NEXT BACKUP, AND (B)(6) WAS THE LAST BACKUP CONTROLLER USED. OF NOTE, (B)(6) ARE LOADED WITH THE ALTERNATE SOFTWARE FOR THE PUMP START ALGORITHM. ADDITIONALLY, THE PUMP ID WAS NOT SET DURING THE INITIAL POWER UP OF CONTROLLERS (B)(6). ADDITIONALLY, MULTIPLE CLOCK CHANGE EVENTS WERE LOGGED FOLLOWING THE INITIAL POWER UP EVENTS FOR (B)(6). IF THE PUMP ID AND DATE ARE NOT SET WHEN THE CONTROLLER IS CONNECTED TO THE MONITOR, THE MONITOR WILL AUTOMATICALLY SET THE CONTROLLER DATE/TIME TO MATCH THE CURRENT DATE/TIME OF THE MONITOR. OF NOTE, THE PUMP ID FOR (B)(6) WAS SET AFTER THE CONTROLLER DATE/TIME WAS ADJUSTED TO MATCH THE MONITOR¿S SETTING. THESE ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED PUMP ID NOT SET IN THE LOG FILES COULD BE ATTRIBUTED TO AN INCORRECT SET UP PROCESS. DUE TO THE ADJUSTMENT IN DATE/TIME ON THE CONTROLLERS, THE SEQUENCE OF EVENTS AFTER THE TIME CHANGES ARE NOT ABLE TO BE DETERMINED. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON (B)(6) 2011 AT 13:08:34 AND 13:08:59, INDICATING A LOSS OF POWER TO THE CONTROLLER. THE DATA POINT RECORDED PRIOR TO THE LOSSES OF POWER REVEALED THAT AN ACTIVE POWER ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 72% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSSES OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF THIRTY FOUR (34) SECONDS. FOLLOWING THE LOSS OF POWER EVENT, ONE (1) VAD STOPPED ALARM WAS LOGGED AT 13:09:18 INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS, WHICH CORRELATES WITH THE HIGH PRIORITY VAD STOP ALARM DESCRIBED IN THE EVENT DETAILS. ADDITIONALLY, FIVE (5) VAD DISCONNECT ALARMS, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER WERE LOG GED BETWEEN 13:25:10 AND 22:35:18, LIKELY DUE TO TROUBLESHOOTING THE VAD STOPPED ALARM. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON (B)(6) 2024 AT 03:45:36 AND 03:47:13 AND A VAD DISCONNECT ALARM AT 03:45:4, INDICATING THAT THE DRIVELINE WAS NOT YET CONNECTED TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER-UP EVENT; THE CONTROLLER LAST HAD POWER ON (B)(6) 2023, INDICATING THAT THE CONTROLLER POWER-UP EVENT AND VAD DISCONNECT ALARM OCCURRED DURING A CONTROLLER EXCHANGE. THE CONTROLLER POWER UP EVENT WAS FOLLOWED BY ONE (1) VAD STOPPED ALARM LOGGED AT 03:47:28, INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS. FOUR (4) VAD DISCONNECT ALARMS, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, WERE LOGGED FOLLOWING THE FAILURE TO RESTART EVENT, LIKELY DUE TO THE REPORTED CONTROLLER EXCHANGE. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED ONE (1) CONTROLLER POWER UP EVENT ON (B)(6) 2024 AT 5:27:37 AND A VAD DISCONNECT ALARM AT 05:27:45, INDICATING THAT THE DRIVELINE WAS NOT YET CONNECTED TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER-UP EVENT; THE CONTROLLER LAST HAD POWER ON (B)(6) 2023, INDICATING THAT THE CONTROLLER POWER-UP EVENT AND VAD DISCONNECT ALARM OCCURRED DURING A CONTROLLER EXCHANGE. THE CONTROLLER POWER UP EVENT WAS FOLLOWED BY ONE (1) VAD STOPPED ALARM LOGGED AT 06:46:41, INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS FOLLOWED BY SEVERAL MORE VAD DISCONNECT ALARMS AND VAD STOPPED ALARMS. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON (B)(6) 2024 AT 06:26:03 AND 06:29:33 IN ADDITION TO TWO (2) VAD DISCONNECT ALARMS AT 06:26:10 AND 06:29:38, INDICATING THAT THE DRIVELINE WAS NOT CONNECTED TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER-UP EVENT; THE CONTROLLER LAST HAD POWER ON (B)(6) 2024, INDICATING THAT THE CONTROLLER POWER-UP EVENT AND VAD DISCONNECT ALARMS OCCURRED DURING A CONTROLLER EXCHANGE. THIS WAS FOLLOWED BY ONE (1) VAD STOPPED ALARM LOGGED AT 06:34:40, INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS FOLLOWED BY SEVERAL MORE VAD DISCONNECT ALARMS AND VAD STOPPED ALARMS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. (B)(6) WAS IN SCOPE OF FCA CVG-21-Q3-21 [SUBGROUP 3], WHICH WAS INITIATED FOR PUMPS WITH FAILURE TO RESTART. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00532915, THE MOST LIKELY ROOT CAUSE OF THE FAILURE TO RESTART EVENT MAY BE ATTRIBUTED TO OUTER SHROUD CONTACT THAT CREATED MORE FRICTION AT THE HOUSING TO IMPELLER INTERFACE. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLERS, LIKELY DUE TO TROUBLESHOOTING AND/OR CONTROLLER EXCHANGE. A POSSIBLE ROOT CAUSE OF THE INITIAL LOSS OF POWER INVOLVING (B)(6) CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE POWER SOURCE. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE SUBSEQUENT LOSSES OF POWER INVOLVING THE OTHER CONTROLLERS ARE DUE TO THE REPORTED CONTROLLER EXCHANGES. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS AND DEATH A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. OF NOTE, THE PATIENT'S REPORTED MEDICAL HISTORY INDICATED THE PATIENT HAD A HISTORY OF THROMBUS. ADDITIONALLY, THE PATIENT WAS ON INTRAVENOUS VASOACTIVE SUPPORT AND TISSUE PLASMINOGEN ACTIVATOR (TPA) DUE TO POSSIBLE THROMBUS. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER D4: MODEL#: 1420/ CATALOG#: 1420 / EXPIRATION DATE: 31-JAN-2023 / SERIAL#: (B)(6). D9: YES. H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 21-JAN-2022 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER D4: MODEL#: 1420/ CATALOG#: 1420 / EXPIRATION DATE: 28-FEB-2022 / SERIAL#: (B)(6). D9: YES H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 17-FEB-2021 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER D4: MODEL#: 1420/ CATALOG#: 1420 / EXPIRATION DATE: UNKNOWN/ SERIAL#: (B)(6). D9: YES H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: UNKNOWN H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER. D4: MODEL#: 1420/ CATALOG#: 1420 / EXPIRATION DATE: UNKNOWN / SERIAL#: (B)(6). D9: YES H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H4: MFG DATE: UNKNOWN. H5: NO. 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 DEVICE EVALUATION. PRODUCT EVENT SUMMARY: ONE (1) PUMP ((B)(6)) AND FOUR (4) CONTROLLERS ((B)(6)) WERE RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED PUMP MET ALL REQUIREMENTS FOR RELEASE. A REVIEW OF THE CONTROLLERS¿ MANUFACTURING DOCUMENTATION WAS NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL EXAMINATION REVEALED ABRASIONS ON THE LOWER HOUSING CERAMIC SURFACE AND ON THE INFERIOR SURFACE OF THE IMPELLER. THESE FRICTION MARKS ARE INDICATIVE THAT AN EXTERNAL FACTOR MAY HAVE FORCED THE IMPELLER AGAINST THE REAR HOUSING WITH SUFFICIENT STRENGTH TO OVERCOME THE REAR PRELOAD OF THE MAGNETIC SPRING/SUSPENSION SYSTEM, THUS LEADING TO SCORING MARKS OBSERVED DURING VISUAL INSPECTION. DIMENSIONAL VERIFICATION REVEALED THAT THE FRONT AND REAR HOUSING DISC CURVATURES WERE FOUND TO BE DEVIATING FROM SPECIFICATIONS. CAPA PR00578223 WAS OPENED TO INVESTIGATE POST-EXPLANT ISSUES FOUND DURING FAILURE ANALYSIS OF RETURNED PUMPS. BIOLOGICAL MATERIAL WAS OBSERVED UPON OPENING OF THE RETURNED PUMP; HOWEVER, THE SAMPLE COULD NOT BE RETRIEVED FOR PATHOLOGICAL EVALUATION SINCE IT WAS FALLING APART. FAILURE ANALYSIS OF THE RETURNED CONTROLLERS REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING. FAILURE ANALYSIS REVEALED THAT (B)(6) PASSED EXTERNAL AND INTERNAL VISUAL INSPECTION. INTERNAL INSPECTION OF (B)(6) REVEALED A CRACK ON STANDOFF POST ONE (1) AND FIVE (5) AND AN INTERNAL INSPECTION OF (B)(6) REVEALED A CRACK ON STANDOFF POST ONE (1) WITHIN THE CONTROLLERS' HOUSINGS. THESE OBSERVED CRACKS ARE ADDITIONAL FINDINGS, NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION, THE ROOT CAUSE OF THE STANDOFF POST CRACK WAS DETERMINED TO BE DUE TO MINERAL OIL APPLIED TO THE CONTROLLER¿S INTERNAL MAIN GASKET AND/OR TO THE SILICONE ADHESIVE APPLIED AROUND THE CONTROLLER¿S INTERNAL BATTERY COMING INTO CONTACT WITH THE STANDOFF POST. THE MINERAL OIL AND/OR SILICONE ADHESIVE CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. CAPA PR00517125 IS INVESTIGATING THIS ISSUE. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PRIMARY CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(6) WAS THE INITIAL BACKUP CONTROLLER, (B)(6) WAS THE NEXT BACKUP, AND (B)(6) WAS THE LAST BACKUP CONTROLLER USED. OF NOTE, (B)(6) ARE LOADED WITH THE ALTERNATE SOFTWARE FOR THE PUMP START ALGORITHM. ADDITIONALLY, THE PUMP ID WAS NOT SET DURING THE INITIAL POWER UP OF CONTROLLERS (B)(6). ADDITIONALLY, MULTIPLE CLOCK CHANGE EVENTS WERE LOGGED FOLLOWING THE INITIAL POWER UP EVENTS FOR (B)(6). IF THE PUMP ID AND DATE ARE NOT SET WHEN THE CONTROLLER IS CONNECTED TO THE MONITOR, THE MONITOR WILL AUTOMATICALLY SET THE CONTROLLER DATE/TIME TO MATCH THE CURRENT DATE/TIME OF THE MONITOR. OF NOTE, THE PUMP ID FOR (B)(6) WAS SET AFTER THE CONTROLLER DATE/TIME WAS ADJUSTED TO MATCH THE MONITOR¿S SETTING. THESE ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED PUMP ID NOT SET IN THE LOG FILES COULD BE ATTRIBUTED TO AN INCORRECT SET UP PROCESS. DUE TO THE ADJUSTMENT IN DATE/TIME ON THE CONTROLLERS, THE SEQUENCE OF EVENTS AFTER THE TIME CHANGES ARE NOT ABLE TO BE DETERMINED. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON 9/APR/2011 AT 13:08:34 AND 13:08:59, INDICATING A LOSS OF POWER TO THE CONTROLLER. THE DATA POINT RECORDED PRIOR TO THE LOSSES OF POWER REVEALED THAT AN ACTIVE POWER ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 72% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSSES OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF THIRTY FOUR (34) SECONDS. FOLLOWING THE LOSS OF POWER EVENT, ONE (1) VAD STOPPED ALARM WAS LOGGED AT 13:09:18 INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS, WHICH CORRELATES WITH THE HIGH PRIORITY VAD STOP ALARM DESCRIBED IN THE EVENT DETAILS. ADDITIONALLY, FIVE (5) VAD DISCONNECT ALARMS, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER WERE LOG GED BETWEEN 13:25:10 AND 22:35:18, LIKELY DUE TO TROUBLESHOOTING THE VAD STOPPED ALARM. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON (B)(6) 2024 AT 03:45:36 AND 03:47:13 AND A VAD DISCONNECT ALARM AT 03:45:4, INDICATING THAT THE DRIVELINE WAS NOT YET CONNECTED TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER-UP EVENT; THE CONTROLLER LAST HAD POWER ON (B)(6) 2023, INDICATING THAT THE CONTROLLER POWER-UP EVENT AND VAD DISCONNECT ALARM OCCURRED DURING A CONTROLLER EXCHANGE. THE CONTROLLER POWER UP EVENT WAS FOLLOWED BY ONE (1) VAD STOPPED ALARM LOGGED AT 03:47:28, INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS. FOUR (4) VAD DISCONNECT ALARMS, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, WERE LOGGED FOLLOWING THE FAILURE TO RESTART EVENT, LIKELY DUE TO THE REPORTED CONTROLLER EXCHANGE. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED ONE (1) CONTROLLER POWER UP EVENT ON (B)(6) 2024 AT 5:27:37 AND A VAD DISCONNECT ALARM AT 05:27:45, INDICATING THAT THE DRIVELINE WAS NOT YET CONNECTED TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER-UP EVENT; THE CONTROLLER LAST HAD POWER ON 14/NOV/2023, INDICATING THAT THE CONTROLLER POWER-UP EVENT AND VAD DISCONNECT ALARM OCCURRED DURING A CONTROLLER EXCHANGE. THE CONTROLLER POWER UP EVENT WAS FOLLOWED BY ONE (1) VAD STOPPED ALARM LOGGED AT 06:46:41, INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS FOLLOWED BY SEVERAL MORE VAD DISCONNECT ALARMS AND VAD STOPPED ALARMS. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON (B)(6) 2024 AT 06:26:03 AND 06:29:33 IN ADDITION TO TWO (2) VAD DISCONNECT ALARMS AT 06:26:10 AND 06:29:38, INDICATING THAT THE DRIVELINE WAS NOT CONNECTED TO THE CONTROLLER. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE POWER-UP EVENT; THE CONTROLLER LAST HAD POWER ON (B)(6) 2024, INDICATING THAT THE CONTROLLER POWER-UP EVENT AND VAD DISCONNECT ALARMS OCCURRED DURING A CONTROLLER EXCHANGE. THIS WAS FOLLOWED BY ONE (1) VAD STOPPED ALARM LOGGED AT 06:34:40, INDICATING THAT THE PUMP FAILED TO RESTART AFTER MULTIPLE ATTEMPTS FOLLOWED BY SEVERAL MORE VAD DISCONNECT ALARMS AND VAD STOPPED ALARMS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. (B)(6) WAS IN SCOPE OF FCA CVG-21-Q3-21 [SUBGROUP 3], WHICH WAS INITIATED FOR PUMPS WITH FAILURE TO RESTART. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00532915, THE MOST LIKELY ROOT CAUSE OF THE FAILURE TO RESTART EVENT MAY BE ATTRIBUTED TO OUTER SHROUD CONTACT THAT CREATED MORE FRICTION AT THE HOUSING TO IMPELLER INTERFACE. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLERS, LIKELY DUE TO TROUBLESHOOTING AND/OR CONTROLLER EXCHANGE. A POSSIBLE ROOT CAUSE OF THE INITIAL LOSS OF POWER INVOLVING (B)(6) CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE POWER SOURCE. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE SUBSEQUENT LOSSES OF POWER INVOLVING THE OTHER CONTROLLERS ARE DUE TO THE REPORTED CONTROLLER EXCHANGES. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS AND DEATH A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. OF NOTE, THE PATIENT'S REPORTED MEDICAL HISTORY INDICATED THE PATIENT HAD A HISTORY OF THROMBUS. ADDITIONALLY, THE PATIENT WAS ON INTRAVENOUS VASOACTIVE SUPPORT AND TISSUE PLASMINOGEN ACTIVATOR (TPA) DUE TO POSSIBLE THROMBUS. 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. ADDITIONAL PRODUCTS: (B)(6) D9: YES, RETURN DATE: 08-JUL-2024 H3: YES (B)(6) D9: YES, RETURN DATE: 08-JUL-2024 H3: YES (B)(6) D9: YES, RETURN DATE: 08-JUL-2024 H3: YES (B)(6) D9: YES, RETURN DATE: 08-JUL-2024 H3: YES 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 WAS SLEEPING WHEN HE WOKE TO A HIGH PRIORITY VAD STOP ALARM.  THE PATIENT CHANGED HIS CONTROLLER TO THEIR BACK UP CONTROLLER AND THE PUMP DID NOT RESTART.  THE PATIENT WENT TO EMERGENCY AND AN UNAPPROVED CONTROLLER WAS TRIED WITHOUT SUCCESS. STAFF WAS TOLD THAT AN UNAPPROVED CONTROLLER WOULD NOT HELP BUT THEY DID TRY USING THE SECOND UNAPPROVED CONTROLLER TO NO AVAIL.  THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) AND IV MEDICATIONS TO TREAT BLOOD PRESSURE AND POSSIBLE THROMBUS WERE INITIATED. LABS WERE DRAWN AND THE LACTATE DEHYDROGENASE (LDH) WAS WITHIN NORMAL LIMITS, INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC.  THE PATIENT WAS PREVIOUSLY BEING TREATED FOR A DRIVELINE INFECTION AND SUSPECTED THROMBUS.  LOGFILES WERE REVIEWED REVEALING MULTIPLE ALARMS, FAILED MOTOR STARTS, MOTOR START EVENT WITH ATYPICAL PARAMETERS, UNEXPECTED POWER LOSS, VAD STOP AND VAD DISCONNECT.  THE PATIENT IS IN THE SUBGROUP 3 POPULATION.  THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192892 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707003261

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death| R| H