MAUDE Adverse Event Report: HEARTWARE HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP; CIRCULATORY ASSIST SYSTEM

Model Number 1104

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)

Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)

Event Date 07/29/2017

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that the patient came into clinic due to a pump that would not restart.The patient's wife described several alarms before pump stopped and could not be restarted; even the backup controller failed starting the pump.The patient was transported to hospital and a brand new controller was used to try and restart the pump but also failed.The patient was admitted to the intensive care unit (icu) and prepped for a pump exchange planned for the following week.The patient remained stable and log files showed several low flow alarms followed by a massive increase in power and then no operation.The left ventricular assist device (lvad) remains implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional devices added to this event: serial # (b)(4), catalog# 1420 exp.Date:03/31/2018.Device available for evaluation: no, device evaluated by mfr: not returned to manufacturer, labeled for single use: no, (b)(4).Serial # (b)(4), catalog# 1420 exp.Date:03/31/2018.Device available for evaluation: no, device evaluated by mfr: not returned to manufacturer, labeled for single use: no, (b)(4).It was further reported that there was suspected thrombus ingestion which made the pump unable to restart.A pump exchange is planned in the near future.No patient complications have been reported as a result of this event.No additional information is available.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Conclusion: pump was not returned for evaluation.(b)(4) were returned for evaluation.A review of the manufacturing documentation confirmed that the associated pump met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the controllers in relation to the reported event.Failure analysis of the returned devices revealed that the controllers passed visual examination and functional testing.The reported pump stop event was confirmed through log file analysis.Log file analysis revealed a decrease in estimated flow of approximately 2 liters per minute (l/min) beginning (b)(6) 2017, followed by a rise in power consumption.The alarm file of (b)(4) revealed that 83 low flow alarms were logged on (b)(6) 2017, 3 high watt alarms were logged on (b)(6) 2017, and 25 vad stopped alarms were logged on (b)(6) 2017; the vad stopped alarms were caused by the pump failing to restart.As a result, the reported "failure of the pump to restart" was confirmed.In addition, a review of (b)(4) event files revealed several controller power up events.The controller power up events were likely d ue an attempt to exchange to the backup (b)(4) and an attempt to troubleshoot the alarms.Analysis of the log files pertaining to the backup controller, (b)(4), revealed 10 vad stopped alarm logged on (b)(6) 2017; several of the vad stopped alarms were due to the pump failing to restart after several attempts.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the available information, the low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the pump, further triggering high watt alarms, thereby causing the pump to stop.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the vad was explanted.

Manufacturer Narrative

Product event summary #n/a.Concomitant medical products: product id: 1420-mcs, serial#: (b)(4).Product id: 1420-mcs, serial#: (b)(4).Additional devices added to this event: serial #: (b)(4).Device available for evaluation: yes, 2017-09-25.Device evaluated by mfr: yes.(b)(4).Product event summary: the reported event details narrative: information indicates that there was suspected thrombus ingestion which made the pump unable to restart.Per vad coordinator patient came into clinic due to a pump that did not restart, patient¿s wife described several alarms before pump stopped and could not be restarted, even the backup controller failed starting the pump.¿ was confirmed via log files.The controller passed visual and functional testing.During review of controller serial (b)(4) log files revealed that this controller was the backup controller.The controller log alarm file revealed a vad stop alarm logged on (b)(6) 2017 at 08:59:36 hours.Additional devices added to this event: serial #: (b)(4).Device available for evaluation: yes, 2017-09-25.Device evaluated by mfr: yes.(b)(4).Product event summary: the reported event details narrative: information indicates that there was suspected thrombus ingestion which made the pump unable to restart.Per vad coordinator patient came into clinic due to a pump that did not restart, patient¿s wife described several alarms before pump stopped and could not be restarted, even the backup controller failed starting the pump.¿ was confirmed via log files.The controller passed visual and functional testing.During review of controller serial (b)(4) log files revealed, a high watts alarm logged on (b)(6) 2017 at 06:42:37 hours followed by the vad stop alarm logged on (b)(6) 2017 at 08:56:55 hours.If information is provided in the future, a supplemental report will be issued.

Event Description

Numerous high watt and vad stop alarms were logged.

Manufacturer Narrative

This event was assessed and is being reported as part of a retrospective review of log file data.Correction: b3, b5, h6 and h10 product event summary: the pump was not returned for evaluation.Con302128 and con302383 were returned for evaluation.A review of the manufacturing documentation confirmed that the associated pump met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the controllers in relation to the reported event.Failure analysis of the returned devices revealed that the controllers passed visual examination and functional testing.The reported ¿low flows followed by high power¿ event was confirmed via review of the controller log files.Log file analysis revealed a decrease in power consumption and estimated flow beginning (b)(6) 2017, followed by a rise in power consumption on (b)(6) 2017.The alarm file of con302128 revealed that eighty-three (83) low flow alarms were logged on (b)(6) 2017, and three (3) high watt alarms, twenty-two (22) vad stopped alarms and three (3) vad disconnect alarms were logged on (b)(6), 2017.The alarm file of con302383 revealed that four (4) additional vad stopped alarms and six (6) vad disconnect alarms were logged on (b)(6), 2017.The event file of con302128 revealed twenty-two (22) controller power up events on (b)(6) 2017.The event file of con302383 revealed four (4) additional controller power up events on july 30, 2017.The controller power up events and vad disconnect alarms were likely due to an attempt to exchange to the backup con302383 and an attempt to troubleshoot the alarms.The vad stopped alarms were caused by the pump failing to restart after several attempts.As a result, the reported "failure of the pump to restart" event was confirmed.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on historical review of similar events, the most likely root cause of the high power may be attributed to external factors such as thrombus formation/ingestion.The low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the pump, resulting in an increase in power and triggering high w att alarms, further resulting in a vad stop.The pump was most likely unable to restart due to the thrombus ingestion.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progr ession 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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 report is being submitted for a revision to the product event summary.Revised product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.(b)(6) were returned for evaluation.A review of the manufacturing documentation confirmed that the associated pump met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the controllers in relation to the reported event.Failure analysis of the returned devices revealed that the controllers passed visual examination and functional testing.The reported ¿low flows followed by high power¿ event was confirmed via review of the controller log files.Analysis of the controller log files revealed a decrease in power consumption and estimated flow beginning july 29, 2017, followed by a rise in power consumption on july 30, 2017.The alarm file of (b)(6) revealed that eighty-three (83) low flow alarms were logged on july 29, 2017, and three (3) high watt alarms, twenty-two (22) vad stopped alarms and three (3) vad disconnect alarms were logged on july 30, 2017.The first vad disconnect alarm was most likely a false alarm, given that the speed recorded at the onset of the alarm was higher than the set speed.This indicates that a possible loss of synchronization of commutation occurred.Commutation is the process of switching winding current to generate motion.If the pump rotational speed drifts higher than the speed set-point, the motor voltage will decrease to achieve the desired speed.However, if there is no change to the speed (speed reading remains frozen), the voltage will continue to decrease to zero.This likely caused the current to decrease to zero, triggering a vad disconnect alarm, even if the driveline was still physically connected to the controller.The alarm file of (b)(6) revealed that four (4) additional vad stopped alarms and six (6) vad disconnect alarms were logged on july 30, 2017.The event file of (b)(6) revealed twenty-two (22) controller power up events on july 30, 2017.The event file of (b)(6) revealed four (4) additional controller power up events on july 30, 2017.The controller power up events and vad disconnect alarms were likely due to an attempt to exchange to the backup (b)(6) and an attempt to troubleshoot the alarms.The vad stopped alarms were caused by the pump failing to restart after several attempts.As a result, the reported "failure of the pump to restart" event was confirmed.Based on historical review of similar events, the most likely root cause of the high power may be attributed to external factors such as thrombus formation/ingestion.The low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the pump, resulting in an increase in power and triggering high watt alarms, further resulting in a vad stop.The pump was most likely unable to restart due to the thrombus ingestion.Possible causes of the vad disconnect alarms can be attributed to a loss of synchronization of commutation leading to a false vad disconnect alarm, and/or physical disconnections of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.H6: the codes present in section h6 correspond to components/products that comprise the reported event.Additional products: d1: controller d4: (b)(6) h3: yes d1: controller d4: (b)(6) 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 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.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: anne schilling ; 8200 coral sea street ne; mounds view, MN 55112-3105 ; 7635052036
• MDR Report Key: 6812342
• MDR Text Key: 83749408
• Report Number: 3007042319-2017-02779
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Weight: 80 KG