MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS

Model Number 1104

Device Problems Failure to Pump (1502); Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 03/08/2022

Event Type  Death  

Event Description

It was reported that ventricular assist device (vad) power was connected to alternating current (ac) adapter electricity and battery power, connected at the same time, when there was a power outage and the patient accidentally took the battery out of the controller with resulting unexpected power loss to two controllers leading to a vad stop.The vad would not restart once reconnected to power.The patient went into cardiac arrest, received some medications and after unsuccessful attempts to resuscitate the patient, the patient expired.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ controller, model #: 1420 / catalog #: 1420 / expiration date: 30-june-2020 / serial#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Mfg date: 03-june-2019, labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ controller, model #: 1420 / catalog #: 1420 / expiration date: 30-june-2020 / serial#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Mfg date: 03-june-2019, labeled for single: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental is being submitted for additional information.Additional products: (b)(6)¿ controller h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19, c23 h6: fda conclusion code(s): d10, d11 (b)(6)¿ controller h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 product event summary: ventricular assist device (vad) (b)(6) and two (2) controllers ((b)(6)) were not returned for evaluation.Log file an alysis revealed that (b)(6) was the patient's primary controller, initially in use at the time of the event.Review of the controller log files associated with (b)(6) revealed this event was initiated by a controller power up event logged on 07-mar-2022 at 2 3:44:30.The data point prior to the loss of power revealed that a controller (b)(6) was connected to power port one (1) with 63% relative state of charge (rsoc) and an active adapter was connected to power port two (2).The data point recorded after the loss of power revealed that (b)(6) was connected to power port (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 eight (8) seconds.Analysis of the alarm log file associated with (b)(6) revealed a vad stopped alarm was then logged on 07-mar-2022 at 23:45:11, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events, additional vad stopped alarms due to a failure of the pump to restart after multiple attempts, and vad disconnect alarms due to a physical disconnection of the driveline from the controller, logged between 07-mar-2022 at: 23:48:26 and 08-mar-2022 at 01:13:58, likely due to troubleshooting and/or the reported controller exchange.Log file analysis associated with (b)(6) revealed a controller power up event logged on 08-mar-2022 at 00:04:23.Additionally, a subsequent vad disconnect alarm was logged at 00:04:27, likely due to the controller powered up without the driveline connected.Review of the log files associated with (b)(6) revealed that the controller last had power on 21-apr-2020, indicating that the power up event and vad disconnect alarm occurred during a controller exchange from (b)(6) to (b)(6).Analysis of the alarm log files associated with (b)(6) revealed a vad stopped alarm on 08-mar-2022 at 00:04:55, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events, additional vad stopped alarms due to a failure of the pump to restart after multiple attempts, and vad disconnect alarms due to a physical disconnection of the driveline from the controller, logged on 08-mar-2022 between 00:15:20 and 01:13:39, likely due to troubleshooting and controller exchanges.As a result, the reported loss of power and failure to restart associated with vad stopped alarms event was confirmed.The most likely root cause of the controller loss of power event can be attributed to the reported disconnection on the one attached power source, as described in the event details.Capa pr00551638 is investigating controller losses of power.Based on the available information, the most likely root cause of the remaining controller power up events can be attributed to troubleshooting of the controllers during controller exchanges.The most likely root cause of the reported vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was in scope of fca cvg-21-q3-21.Capa pr00502194 is investigating pump failures to restart.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.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.

Manufacturer Narrative

A supplemental correction is being submitted for inclusion of this event as being in-scope for recall with z-0946-2021.This event was submitted historically and has been deemed in-scope for the field corrective action.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.

Manufacturer Narrative

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 at the time of the event.Review of the controller log files associated with (b)(6) revealed this event was initiated by a controller power up event logged on 07-mar-2022 at 23:44:30.The data point prior to the loss of power revealed that a controller (b)(6) was connected to power port one (1) with 63% relative state of charge (rsoc) and an active adapter was connected to power port two (2).The data point recorded after the loss of power revealed that (b)(6) was connected to power port (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 eight (8) seconds.Analysis of the alarm log file associated with (b)(6) revealed a vad stopped alarm was then logged on 07-mar-2022 at 23:45:11, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events, additional vad st opped alarms due to a failure of the pump to restart after multiple attempts, and vad disconnect alarms due to a physical disconnection of the driveline from the controller, logged between 07-mar-2022 at: 23:48:26 and 08-mar-2022 at 01:13:58, likely due to troubleshooting and/or the reported controller exchange.After the losses of power, safety alert word (saw) values were recorded on both of the connected power sources, indicating an overcurrent alert.It is likely that the overcurrent condition prevented the batteries from providing power, resulting in losses of power to the controller.Log file analysis associated with (b)(6) revealed a controller power up event logged on 08-mar-2022 at 00:04:23.Additionally, a subsequent vad disconnect alarm was logged at 00:04:27, likely due to the controller powered up without the driveline connected.Review of the log files associated with (b)(6) revealed that the controller last had power on 21-apr-2020, indicating that the power up event and vad disconnect alarm occurred during a controller exchange from (b)(6).Analysis of the alarm log files associated with (b)(6) revealed a vad stopped alarm on 08-mar-2022 at 00:04:55, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events, additional vad stopped alarms due to a failure of the pump to restart after multiple attempts, and vad disconnect alarms due to a physical disconnection of the driveline from the controller, logged on 08-mar-2022 between 00:15:20 and 01:13:39, likely due to troubleshooting and controller exchanges.After the losses of power, saw values were recorded on both of the connected power sources, indicating an overcurrent alert.It is likely that the overcurrent condition prevented the batteries from providing power, resulting in additional losses of power to the controller.As a result, the reported loss of power and failure to restart associated with vad stopped alarms event was confirmed.The most likely root cause of the initial loss of power can be attributed to the reported disconnection of both power sources from the controller as described in the event details.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller losses of power due to battery discharge overcurrent conditions during pump start attempts.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was in scope of fca cvg-21-q3-21.Capa pr00502194 is investigating pump failures to restart.Based on an investigation conducted under capa pr00502194, 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.Even though this capa is now closed, (b)(6) falls within the bounds of this capa.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13722343
• MDR Text Key: 286944313
• Report Number: 3007042319-2022-02926
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0946-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 60 KG