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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problem
Failure to Pump (1502)
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| Patient Problems
Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Hemoptysis (1887); Thrombus (2101); Heart Failure/Congestive Heart Failure (4446)
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| Event Date 01/19/2020 |
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Event Type
Death
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.Additional products: heartware ventricular assist system controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation? yes, return date: 22-jan-2020.Device evaluated by mfr? no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 01-oct-2018.Labeled for single use? no(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the controller exhibited a ventricular assist device (vad) stopped alarm, with a secondary message to change the controller.The patient's mother performed a controller exchange to the backup for the left (vad), as well as to the backup for the right vad (rvad) however the lvad would not restart.It was suspected that the lvad was clotted and shut down, and that the rvad, which was still functional, flooded the lungs.The patient began vomiting blood.The patient was taken to the emergency room, and was pronounced dead.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Product event summary: two ventricular assist devices (vads) ((b)(4) and (b)(4)) and two controllers ((b)(4) and (b)(4)) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of the manufacturing records confirmed that the associated vad ((b)(4)) met all requirements prior to release.Based on the available information, it was determined that that vad ((b)(4)) was implanted on the left ventricle and vad ((b)(4)) was implanted on the right ventricle.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned vad ((b)(4)) revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed evidence of thrombus within the vad (b)(4).Failure analysis of the returned vad ((b)(4)) revealed that the device passed visual examination and dimensional verification.Post-explant functional analysis revealed that the vad (b)(4) deviated from pre-implant requirements, with power average consumption of 2.07 watts vs 2.03 watts.Since this deviation in power was not present prior to release of the device, it was most likely introduced during use and does not affect the functionality of the vad.Internal pathological report revealed no evidence of thrombus within the vad (b)(4).Review of controller ((b)(4)) log files associated with vad ((b)(4)) revealed 14 critical battery alarms due to the batteries depleting below 10% relative state of charge (rsoc) starting at 02:37:36 and four controller fault alarms logged on (b)(6) 2020 starting at 03:47:48.A controller fault alarm will occur if the battery is approaching 0% rsoc.Log file analysis revealed that, at the time of the first critical battery alarm, a battery was connected to power port one with 20% rsoc and another battery was connected to power port two with 9% rsoc.Both batteries were then allowed to deplete completely.No anomalies were observed with the power consumption and power management of the batteries; the batteries discharged and behaved as expected.A controller power up event was then logged on at 04:15:45.The data point recorded before the power up event revealed that the same battery was connected to power port one and the same battery was connected to power port two; both batteries were allowed to deplete completely, resulting in a loss of power to the controller.The data point recorded after the power up revealed that no power source was connected to power port one and a new battery was connected to power port two.The controller was without power for 17 minutes and 11 seconds.A vad stopped alarm was then recorded at 04:16:23 due to a failure of the vad to restart after several attempts.This was followed by multiple vad disconnect alarms indicating a physical disconnection of the driveline from the controller, which likely corresponds with the reported controller exchange and troubleshooting, with several more vad stopped alarms.Several additional controller power up events were logged on (b)(6) 2020 through 05:17:15, likely due to troubleshooting of the device.65 suction alarms and 12 low flow alarms were logged starting from (b)(6) 2020.Review of the controller ((b)(4)) log files associated with vad ((b)(4)) revealed a controller power up event on (b)(6) 2020 at 04:38:18.Review of the data log files revealed that the controller was not in use prior to the reported event, and was likely the patients back-up controller assigned to vad (b)(4).Based on the reported event details, backup controller ((b)(4)) was likely used to troubleshooting the alarms associated with vad ((b)(4)).A vad stopped alarm was then recorded at 04:38:39 due to a failure of the vad to restart after several attempts.This was followed by a vad disconnect alarm indicating a physical disconnection of the driveline from the controller.Review of the controller ((b)(4)) log files associated with vad (b)(4), revealed a vad disconnect alarm was logged on (b)(6) 2020 at 05:26:31 indicating a physical disconnection of the driveline from the controller.Log file analysis also revealed intermittent suction events during the analyzed period and three suction alarms recorded on (b)(6) 2020.Additionally, 12 low flow alarms were recorded since (b)(6) 2020.As a result, the reported event was confirmed.Based on the risk documentation, possible causes of the observed low flow/suction events 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, inappropriate vad rotational speed.The most likely root cause of the critical battery, controller fault alarms, and loss of power can be attributed to the patient allowing batteries to depleting below 10%.The most likely root cause of the vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the vad stopped alarm can be attributed to failure of the vad to restart after several attempts.Based on historical review, the likely contributing cause for failure to restart was the inability of the vad-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.Possible clinical factors that may have contributed to this event include the patients pre-existing condition of cardiomyopathy, 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: serial #: (b)(4), device evaluated by manufacturer: yes, heartware ventricular assist system controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 30-sep-2019 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: yes, return date: 09-mar-2020, device evaluated by manufacturer: yes, dev rtn to mfr? yes, mfg date: 28-sep-2018, labeled for single use: no.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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The backup controller was returned to the manufacturer and subsequently tested out of specification during manufacturer's analysis.
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Manufacturer Narrative
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A supplemental report is being submitted for a correction, updated device analysis, and updated investigation completion.The recall number was corrected from being left blank in a previous report.Product event summary: two (2) ventricular assist devices (vads) ((b)(4)) and three (3) controllers ((b)(4)) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of the manufacturing records confirmed that the associated vad (b)(4) met all requirements prior to release.Based on the available information, it was determined that the vad (b)(4) was implanted on the left ventricle and vad (b)(4) was implanted on the right ventricle.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned vad (b)(4) revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed evidence of thrombus within the vad (b)(4).Failure analysis of the returned vad (b)(4) revealed that the device passed visual examination and dimensional verification.Post-explant functional analysis revealed that the vad (b)(4) deviated from pre-implant requirements, with power average consumption of 2.07 watts vs 2.03 watts.Since this deviation in power was not present prior to release of the device, it was most likely introduced during use and does not affect the functionality of the vad.Internal pathological report revealed no evidence of thrombus within the vad (b)(4).Review of controller (b)(4) log files associated with vad (b)(4) revealed 14 critical battery alarms due to the batteries depleting below 10% relative state of charge (rsoc) starting at 02:37:36 and 4 controller fault alarms logged on (b)(6) 2020 starting at 03:47:48.A controller fault alarm will occur if the battery is approaching 0% rsoc.Log file analysis revealed that, at the time of the first critical battery alarm, a battery was connected to power port 1 with 20% rsoc and another battery was connected to power port 2 with 9% rsoc.Both batteries were then allowed to deplete completely.No anomalies were observed with the power consumption and power management of the batteries; the batteries discharged and behaved as expected.A controller power up event was then logged on at 04:15:45.The data point recorded before the power up event revealed that the same batteries were connected to power ports 1 and 2; both batteries were allowed to deplete completely, resulting in a loss of power to the controller.The data point recorded after the power up revealed that no power source was connected to power port 1 and a different battery was connected to power port 2.The controller was without power for 17 minutes and 11 seconds.A vad stopped alarm was then recorded at 04:16:23 due to a failure of the vad to restart after several attempts.This was followed by multiple vad disconnect alarms indicating a physical disconnection of the driveline from the controller, which likely corresponds with the reported controller exchange and troubleshooting, with several more vad stopped alarms.Several additional controller power up events were logged on (b)(6) 2020 through 05:17:15, likely due to troubleshooting of the device.65 suction alarms and 12 low flow alarms were logged starting from (b)(6) 2020.Review of the controller (b)(4) log files associated with vad (b)(4) revealed a controller power up event on (b)(6) 2020 at 04:23:42.Review of the data log files revealed that the controller was not in use leading up to the reported event.The controller (b)(4) was likely the patient¿s back-up controller and was used to troubleshooting the alarms associated with (b)(4).A vad stopped alarm was then recorded at 04:24:03 due to a failure of the vad to restart after several attempts.This was followed by a vad disconnect alarm indicating a physical disconnection of the driveline from the controller.Review of the controller (b)(4) log files associated with vad (b)(4) revealed a controller power up event on (b)(6) 2020 at 04:38:18.Review of the data log files revealed that the controller was not in use prior to the reported event, and was likely the patients back-up controller assigned to vad (b)(4).Based on the reported event details, backup controller (b)(4) was likely used to troubleshooting the alarms associated with vad (b)(4).A vad stopped alarm was then recorded at 04:38:39 due to a failure of the vad to restart after several attempts.This was followed by a vad disconnect alarm indicating a physical disconnection of the driveline from the controller.Review of additional controller log files associated with vad (b)(4) revealed a vad disconnect alarm was logged on (b)(6) 2020 at 05:26:31, indicating a physical disconnection of the driveline from the controller.Log file analysis also revealed intermittent suction events during the analyzed period and three (3) suction alarms recorded on (b)(6) 2020.Additionally, 12 low flow alarms were recorded since (b)(6) 2020.As a result, the reported event was confirmed.Information received from the site indicated that the patient presented with suspected thrombus, vomiting blood, and subsequently expired.Per the instructions for use, thrombus and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a hi story of similar adverse events.Based on the risk documentation, possible causes of the observed low flow/suction events 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, inappropriate vad pump rotational speed.The most likely root cause of the critical battery, controller fault alarms, and loss of power can be attributed to the patient allowing batteries to depleting below 10%.The most likely root cause of the vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the vad stopped alarms can be attributed to failure of the vad to restart after several attempts.Capa (b)(4) is investigating vad failures to restart.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing condition of cardiomyopathy, 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: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2019 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: yes, return date: 28-jan-2021, device evaluated by manufacturer: yes, dev rtn to mfr? yes, device mfg date: 01-oct-2018, labeled for single use: no, (b)(4).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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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An additional controller was returned to the manufacturer and subsequently tested out of specification during manufacturer's analysis.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Additional information was received regarding the recall number.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.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A supplemental report is being submitted for a correction and additional information.Newly received information provided additional details from the time of the patient's death.Section h10 additional products was corrected to provide analysis codes for controller con403419 which were erroneously omitted from a previous report.Additional products: controller 2.0 con403440 h6: patient ime code(s): e233001, e0602, e0611 controller 2.0 con403399 h6: patient ime code(s): e233001, e0602, e0611 controller 2.0 con403419 h6: patient ime code(s): e233001, e0602, e0611 h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d1: heartware ventricular assist system ¿ instructions for use d4: model #: ifu00376 / catalog #: ifu00376 d9: no h5: no h6: patient ime code(s): e233001, e0602, e0611, e0514, e0721 h6: imf code(s): f02 h6: img code(s): g04080 h6: fda device code(s): a21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 investigation of this event is pending and a supplemental report will be sent upon its completion.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.
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Event Description
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It was further reported that the patient had awoken with chest pain and, after multiple attempts to restart the vad, experienced heart failure and cardiac arrest.It was also reported that the instructions for use (ifu) was defective.
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Manufacturer Narrative
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A supplemental report is being submitted for investigation completion.Updates to the product event summary are indicated below: product event summary: the instructions for use (ifu) with unknown lot number was not returned for evaluation.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface.Power deviations are being investigated under capa pr00532915.After the vad stopped alarms, a safety alert word (saw) value was recorded on the batteries, indicating an overcurrent alert.It is likely the overcurrent condition prevented the batteries from providing power, resulting in the additional losses of power to the controller.There is insufficient information regarding the reported " instructions for use (ifu) was defective" event.As a result, the reported defective ifu event could not be confirmed.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller loss of power during pump start due to battery discharge overcurrent condition.(b)(6) is part of fca cvg-21-q3-21.Controller 2.0 con403440 h6: fda results code(s): c21, c23 h6: fda conclusion code(s): d16 instructions for use ifu00376 h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d14 an internal investigation is pending.A report will be sent when root cause for the internal investigation has been determined.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.
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Search Alerts/Recalls
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