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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problem
Failure to Pump (1502)
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| Patient Problems
Right Ventricular Failure (2055); No Consequences Or Impact To Patient (2199)
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| Event Date 05/30/2020 |
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Event Type
Injury
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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: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1403us / catalog #: 1403us / expiration date: 30-sep-2019/ serial: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun dev rtn to mfr? no, mfg date: 19-sep-2018, labeled for single use: no, (b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.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 there was a double disconnect of power sources from the controller.Once the power sources were reconnected to the controller the ventricular assist device (vad) would not restart.Troubleshooting was done with several controllers but the pump would not restart.The controller was removed from service and the vad remains implanted but turned off.No patient complications have been reported as a result of this event.
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Event Description
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It was further reported that the patient was brought to the operating room (or) for a vad exchange.The patient arrived in the or with a temporary heart pump in place.The temporary heart pump was removed and a right vad was implanted and the left vad was exchanged.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Update to patient outcome (b2), the event description (b5), explant date (d7), type of event (h1), and pateint codes (h2).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.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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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation and additional information in b5 and h10.Product event summary: the pump and controllers 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.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Failure analysis of the returned controller (con403116) revealed that the device passed visual inspection and functional testing.Failure analysis of the returned controller (con403118) revealed that the device passed functional testing.Visual inspection revealed contamination within both power ports of the controller.This is an additional finding not related to the reported event, likely due to the handling of the device.Review of the controller log files associated with controller con403118 revealed a controller power up event on (b)(6) 2020 at 15:09:48.The data point prior to the loss of power revealed that a battery was connected to power port one (1) with 63% relative state of charge (rsoc) and a second battery was connected to power port two (2) with 23% rsoc.The data point recorded after the loss of power revealed that two different batteries were connected.The controller was without power for 15 seconds.A vad stopped alarm was then logged at 15:10:30 due to a failure of the pump to restart after several attempts.This was followed by additional controller power up events, vad stopped alarms and vad disconnect alarms, likely due to troubleshooting.Review of the controller log files associated with controller con403116 revealed a controller power up event on (b)(6) 2020 at 15:14:05.Additionally, review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point since on (b)(6) 2019 was logged at 15:14:38 on (b)(6) 2020, indicating that the power up event occurred during a controller exchange, which corresponds with the reported event details.A vad stopped alarm was then logged at 15:15:03 due to a failure of the pump to start after multiple attempts.This was followed by additional controller power up events, vad stopped alarms, and vad disconnect alarms due to the physical disconnection of the driveline from the controller, likely due to troubleshooting.Several additional vad disconnect alarms were recorded on con403116 on (b)(6) 2020 at 15:29:18 and 15:44:53.An analysis of the alarm file revealed that the vad disconnect alarms were most likely false alarms, 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.Furthermore, two (2) power disconnect alarms were observed at 15:33:51 and 15:35:24.During the power disconnect alarms, a safety alert word (saw) value was recorded indicating an overcurrent alert.At the time of the power disconnect alarms with an overcurrent alert, the alarm log recorded high power consumption, indicating a higher current consumption from the battery.The battery was most likely physically disconnected by the patient, causing the controller to log this event as a power disconnect alarm.As a result, the reported event was confirmed.Based on the available information, a possible root cause of the vad disconnect alarms associated with con403116 on (b)(6) 2020 at 15:29:18 and 15:44:53 can be attributed to a loss of synchronization of commutation, leading to false vad disconnect alarms.The most likely root cause of the loss of power associated with con403118 on (b)(6) 2020 at 15:09:48 can be attributed to the reported disconnection of both power sources from the controller as described in the event details.The most likely root cause of the additional vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.Based on historical review of similar events, the likely contributing cause for failures to restart was the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: con403118 d10: dev rtn to mfr? yes, 07-jul-2020, h3: yes, h6: method code(s): 10, 4112 h6: results code(s): 331, 213 h6: conclusion code(s): 19, 4310, additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model#: 1403us / catalog#: 1403us / expiration date: 30-sep-2019 / serial: (b)(6), udi#: (b)(4), d10: dev rtn to mfr? yes, 07-jul-2020, h3: yes, h4: mfg date: 19-sep-2018, h5: no, h6: patient code(s): c50675 h6: device code(s): c63217 h6: method code(s): 10, 4112 h6: results code(s): 213, 120 h6: conclusion code(s): 4307, 4310.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.
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Event Description
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It was further reported that a second controller was returned to the manufacturer and subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.
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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.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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Manufacturer Narrative
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A supplemental report is being submitted for device analysis.Product event summary: (b)(6) was returned for evaluation.Review of the manufacturing records confirmed that the associated pump met all requirements prior to release.Log file analysis revealed that (b)(6) was the patient¿s primary controller initially in use at the time of the reported event.Log file analysis associated with (b)(6) revealed a controller power-up event on 30-may-2020 at 15:09:48, indicating a loss of power to the controller.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 63% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 23% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for 15 seconds.A vad stopped alarm was then logged at 15:10:30 due to a failure of the pump to restart after several attempts.This was followed by additional controller power up events, vad stopped alarms due to a failure of the pump to restart after several attempts, and vad disconnect alarms indicating physical disconnections of the driveline from the controller, likely due to troubleshooting.After several controller power up events during the pump start attempts, log file analysis revealed that safety alert word (saw) values were recorded on (b)(6), indicating an overcurrent alert.During the attempted pump start events, log files recorded high power consumption, which required more current from the batteries.It is likely that the overcurrent condition prevented the batteries from providing power, resulting in additional losses of power to the controller.Review of the controller log files associated with controller con403116 revealed a controller power-up event on 30-may-2020 at 15:14:05.Additionally, review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point since 02-oct-2019 was logged at 15:14:38 on 30-may-2020, indicating that the power up event occurred during a controller exchange, which corresponds with the reported event details.A vad stopped alarm was then logged at 15:15:03 due to a failure of the pump to start after multiple attempts.This was followed by additional controller power-up events, vad stopped alarms due to a failure of the pump to restart after several attempts, and vad disconnect alarms due to the physical disconnection of the driveline from the controller, likely due to troubleshooting.Several additional vad disconnect alarms were recorded on con403116 on 30-may-2020 at 15:29:18 and 15:44:53.An analysis of the alarm file revealed that the vad disconnect alarms were most likely false alarms, 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.Furthermore, two (2) power disconnect alarms were observed involving (b)(6) at 15:33:51 and 15:35:24.During the power disconnect alarms, saw values were recorded indicating an overcurrent alert.The battery was most likely physically disconnected by the patient, causing the controller to log this event as a power disconnect alarm.Additionally, log file analysis revealed that saw values were recorded on (b)(6) during motor start attempts indicating an overcurrent alert.During the attempted pump start events, log files recorded high power consumption, which required more current from the batteries.It is likely that the overcurrent condition prevented the batteries from providing power, resulting in additional losses of power to the controller.During an attempted pump start event, several controller reset events were logged between 15:49:04 and 15:56:25.During the controller reset events, the controller's internal logs revealed instances that only one power source was connected to the controller leading up to the attempted pump start.Post-explant functional analysis revealed that pump hw40454 met pre-implant requirements with power average consumption of 1.95 watts.Visual examination did not identify any discrepancies that may have caused or contributed to the reported event.There was no indication of mechanical abrasion or abnormal wear of the impeller or on the pump housing surfaces.Internal pathological report revealed no evidence of thrombus within the device.Dimensional verification revealed that the front housing disc curvature was found to be deviating from release specifications.Further analysis revealed that the impeller could potentially contact the front housing at its outer shroud, which leads to increased starting friction at the housing to impeller interface.H6: the codes present in section h6 correspond to components/products that comprise the reported 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 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.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 device analysis.Product event summary: one (1) pump ((b)(6)) and two (2) controllers ((b)(6)) 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.A review of (b)(6)s manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned controller ((b)(6)) revealed that the device passed visual inspection and functional testing.Failure analysis of the returned controller ((b)(6)) revealed that the device passed functional testing.Visual inspection revealed contamination within both power ports of the controller.This is an additional finding not related to the reported event, likely due to the handling of the device.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front housing disc curvature was found to be deviating from release specifications.Further analysis revealed that the impeller could potentially contact the front housing at its outer shroud, which leads to increased starting friction at the housing to impeller interface; this increase in friction is being investigated under the capa pr00502194 investigation.Internal pathology report revealed evidence of thrombus within the pump.Log file analysis revealed that (b)(6) was the patient¿s primary controller initially in use at the time of the reported event.Log file analysis associated with (b)(6) revealed a controller power-up event on (b)(6) 2020 at 15:09:48, indicating a loss of power to the controller.The data point prior to the loss of power revealed that bat804887 was connected to power port one (1) with 63% relative state of charge (rsoc) and bat804415 was connected to power port two (2) with 23% rsoc.The data point recorded after the loss of power revealed that bat804379 was connected to power port one (1) and bat806105 was connected to power port two (2).The controller was without power for 15 seconds.A vad stopped alarm was then logged at 15:10:30 due to a failure of the pump to restart after several attempts.This was followed by additional controller power up events, vad stopped alarms due to a failure of the pump to restart after several attempts, and vad disconnect alarms indicating physical disconnections of the driveline from the controller, likely due to troubleshooting.After several controller power up events during the pump start attempts, log file analysis revealed that safety alert word (saw) values were recorded on bat804407 and bat806105, indicating an overcurrent alert.During the attempted pump start events, log files recorded high power consumption, which required more current from the batteries.It is likely that the overcurrent condition prevented the batteries from providing power, resulting in additional losses of power to the controller.Review of the controller log files associated with controller (b)(6) revealed a controller power-up event on (b)(6) 2020 at 15:14:05.Additionally, review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point since (b)(6) 2019 was logged at 15:14:38 on (b)(6) 2020, indicating that the power up event occurred during a controller exchange, which corresponds with the reported event details.A vad stopped alarm was then logged at 15:15:03 due to a failure of the pump to start after multiple attempts.This was followed by additional controller power-up events, vad stopped alarms due to a failure of the pump to restart after several attempts, and vad disconnect alarms due to the physical disconnection of the driveline from the controller, likely due to troubleshooting.Several additional vad disconnect alarms were recorded on (b)(6) on (b)(6) 2020 at 15:29:18 and 15:44:53.An analysis of the alarm file revealed that the vad disconnect alarms were most likely false alarms, 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.Furthermore, two (2) power disconnect alarms were observed involving bat804859 at 15:33:51 and 15:35:24.During the power disconnect alarms, saw values were recorded indicating an overcurrent alert.The battery was most likely physically disconnected by the patient, causing the controller to log this event as a power disconnect alarm.Additionally, log file analysis revealed that saw values were recorded on bat804407 and bat804859 during motor start attempts indicating an overcurrent alert.During the attempted pump start events, log files recorded high power consumption, which required more current from the batteries.It is likely that the overcurrent condition prevented the batteries from providing power, resulting in additional losses of power to the controller.During an attempted pump start event, several controller reset events were logged between 15:49:04 and 15:56:25.During the controller reset events, the controller's internal logs revealed instances that only one power source was connected to the controller leading up to the attempted pump start.As a result, the reported event was confirmed.Based on the available information, the device may have caused or contributed to the reported event.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 a physical disconnection of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.The most likely root cause of the loss of power associated with con403118 on 30-may-2020 at 15:09:48 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 loss of power during pump start due to battery discharge overcurrent condition.Capa pr00609659 is investigating controller resets during pump start.A possible root cause of the power disconnect alarms may be attributed, but not limited, to a physical disconnection of the power sources.The most likely root cause of the additional controller power-up events can be attributed to controller exchanges and troubleshooting of the vad stopped alarms.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after multiple attempts.(b)(6) is in scope of fca cvg-21-q3-21, which was initiated for pumps with failure to restart.Capa pr00502194 investigated 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.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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