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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS
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| Model Number 1104 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)
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| Patient Problem
Death (1802)
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| Event Date 11/23/2018 |
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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.Other devices involved in this event: heartware ventricular assist system - controller: model #: unk-controller / expiration date: unknown, udi #: asku, mfg date: unknown, (b)(4).Heartware ventricular assist system - controller: model #: unk-controller / expiration date: unknown, udi #: asku, mfg date: unknown, (b)(4).Model #: unk-battery / expiration date: unknown, udi #: asku, mfg date: unknown, (b)(4).Model #: 1440 / expiration date: unknown, udi #: asku, mfg date: unknown, (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 patient has visited the hospital and reported no issues with the ventricular assist device (vad).The patient was returning home in hospital transport and was trying to switching from dc power to battery power when the controller failed.The screen was reportedly blank and had a high priority alarm.The patient attempted to exchange the controller, but the backup controller also experienced a controller fault.The patient then lost consciousness and resuscitation was attempted by the ambulance driver, paramedics, and local hospital where the patient was taken.Attempts were also made to change power sources but the vad would no restart.Resuscitation attempts were stopped and the patient subsequently expired.It was further reported that the patient had been having regular alarms prior to the hospital visit.The device remains implanted.
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Manufacturer Narrative
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Other devices involved in this event: heartware ventricular assist system ¿ controller 2.0 , (b)(4)/model #: 1420/expiration date: 2018-03-31, udi #: asku.Mfg date: 2017-03-31.Heartware ventricular assist system ¿ controller 2.0, (b)(4)/model #: 1420/expiration date: 2018-07-31, udi #: asku.Mfg date: 2017-07-31.(b)(4).Heartware ventricular assist system ¿ battery, (b)(4)/model #: 1650de/expiration date: 2018-07-31 udi #: asku, mfg date: 2017-07-31.Heartware ventricular assist system ¿ controller dc adapter.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 ventricular assist device (vad) was explanted for analysis.
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Event Description
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It was further reported that an additional battery was noted to have experienced regular alarms.
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Manufacturer Narrative
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Product event summary: the battery was returned for evaluation.Failure analysis of the returned battery revealed that the device passed visual inspection and functional testing.A review of the available log files for this battery revealed no findings.Other devices involved in this event: brand name: heartware ventricular assist system ¿ battery.Model 1650de, serial number: (b)(4), expiration date: 31-aug-2108, udi: (b)(4).Device available for evaluation: yes, 05-feb-2019.Mfg date: 31-aug-2107.Patient codes(s): c28554.Device code(s): c63030.Method code(s): 10, 4112.Result code(s): 213.Conclusion code(s): 67.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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Product event summary: the hvad pump, two controllers, four batteries, and one controller dc adapter 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 devices in relation to the reported event.Failure analysis of the returned controllers, batteries, and controller dc adapter revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned pump revealed that the device passed visual examination.Post-explant functional analysis revealed that the pump deviated from pre-implant requirements, with power average consumption of 2.07 watts vs 2.03 watts.Given that this deviation in power was not present prior to release of the device, it was most likely introduced during use.Additionally, dimensional verification revealed that front housing disc curvature and back preload measurement were found to be deviating from specifications.Given that the pump met specifications prior to release, these deviations were likely a result of the clinical challenge to the pump and not the initial source of the reported event.As such, these are additional observations not related to the reported event.Internal pathological report revealed no evidence of thrombus within the device.A review of the available log files revealed that (b)(4) was initially in use at the time of the reported event.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15 minute interval.Analysis of the data log files revealed several momentary disconnections involving (b)(4).There is no evidence that the lubrication servicing was performed on the reported devices.Momentary disconnections will result in an audible tone, which were likely perceived as the reported ¿regular alarms.¿ as a result, the reported ¿alarms¿ event was confirmed.Analysis of the log files associated with (b)(4) revealed a controller power-up event on (b)(6) 2018 at 22:13:09, indicating a loss of power to the controller.The data point prior to the loss of power revealed that an active adapter was connected to power port one and (b)(4) was connected to power port two with 47% relative state of charge (rsoc).The data point recorded after the loss of power revealed that (b)(4) was connected to power port one and (b)(4) was connected to power port two.The controller was without power for 10 seconds.During a loss of power to the controller, the controller display screen will be blank and the controller will emit a loud, continuous alarm.A vad stopped alarm was then logged at 22:13:50, indicating that the motor failed to restart after multiple attempts.7 additional losses of power, 4 additional vad stopped alarms, and 4 vad disconnect alarms, indicating physical disconnections of the driveline from the controller, were logged between 22:28:42 and 23:27:41.Log file analysis revealed that (b)(4) was subsequently in use.Analysis of the log files associated with (b)(4) revealed 6 losses of power, 3 vad stopped alarms due to the failure of the pump to restart after multiple attempts, and 4 vad disconnect alarms, indicating physical disconnections of the driveline from the controller, logged between 22:25:50 and 23:36:29.As a result, the reported ¿blank screen and high priority alarm¿ and ¿vad would not restart¿ events were confirmed.The most likely root cause of the reported ¿regular alarms¿ can be attributed to momentary disconnections between the controller and batteries.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.An internal investigation examined momentary disconnections.An internal investigation was initiated to capture events involving the controller losing power and failures of the pump to restart at the system level (interaction between the pump and peripheral devices).Based on an extensive investigation conducted under the internal investigation, the likely contributing causes for failure to restart come from the presence of increased starting resistance in a very small number of implanted patients.This resistance is likely specific to the physiology of these patients, an area of limited access for further investigation.Therefore, no actionable root causes were identified.Additional products: serial #: (b)(4), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, fda method code(s): 10, 4112, fda results code(s): 3213, 213, fda conclusion code(s): 12, 4310.Serial #: (b)(4), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, fda method code(s): 10, 4112, fda results code(s): 213, fda conclusion code(s): 4310.: serial #: (b)(4), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, fda method code(s): 10, 4112 , fda results code(s): 3213, fda conclusion code(s): 12.Serial #: (b)(4), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, fda method code(s): 10, 4112, fda results code(s): 213 ,fda conclusion code(s): 67.Brand name: heartware ventricular assist system ¿ battery, model #: 1650de / catalog #: 1650de / expiration date: 31-aug-2018 / serial or lot#: (b)(4), udi #: (b)(4), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, device mfg date: 31-aug-2017, labeled for single use: no, patient code(s):c28554, device code(s): c63030, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12.Brand name: heartware ventricular assist system ¿ battery, model #: 1650de / catalog #: 1650de / expiration date: 31-aug-2016 / serial or lot#: (b)(4), udi #: (b)(), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, device mfg date: 31-aug-2015, labeled for single use: no, patient code(s):c28554, device code(s): c63030, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12.Brand name: heartware ventricular assist system ¿ battery, model #: 1650de / catalog #: 1650de / expiration date: 31-aug-2018 / serial or lot#: (b)(4), udi #: (b)(4), returned to manufacturer: yes, return date: 05-feb-2019, device evaluated by manufacturer: yes, dev rtn to mfr? yes, device mfg date: 31-aug-2017, labeled for single use: no, patient code(s):c28554, device code(s): c63030, fda method code(s): 10, 4112 , fda results code(s): 3213, fda conclusion code(s): 12.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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Event Description
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It was further reported that three additional batteries were returned to the manufacturer for analysis.The batteries 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 revision to the product event summary.Revised product event summary: the ventricular assist device (vad) ((b)(6)), two (2) controllers ((b)(6)), five (5) b atteries ((b)(6)), and one (1) controller dc adapter ((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 devices in relation to the reported event.Failure analysis of the returned controllers, batteries, and controller dc adapter revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned pump revealed that the device passed visual examination.Post-explant functional analysis revealed that the pump (b)(6) deviated from pre-implant requirements, with power average consumption of 2.07 watts vs 2.03 watts.Given that this deviation in power was not present prior to release of the device, it was most likely introduced during use.Additionally, dimensional verification revealed that front housing disc curvature and back preload measurement were found to be deviating from specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of retur ned pumps.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 that the controller contained a software feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files revealed several momentary disconnections involving (b)(6).There is no evidence that the lubrication servicing was performed on the reported devices.Momentary disconnections will result in an audible tone, which were likely perceived as the reported ¿regular alarms.¿ as a result, the reported ¿alarms¿ event was confirmed.The most likely root cause of the reported ¿regular alarms¿ event can be attributed to momentary disconnections between the controller and batteries.Capa pr00389403 investigated momentary disconnections prior to lubrication servicing.Even though this capa is closed, (b)(6) fall within the bounds of this capa.Log file analysis associated with (b)(6) also revealed a c ontroller power-up event on 23/nov/2018 at 22:13:09, indicating a loss of power to the controller.The data point prior to the loss of power revealed that an active adapter was connected to power port one (1) and (b)(6) was connected to power port two (2) with 47% relative state of charge (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 10 seconds.No anomalies were recorded leading up to the initial loss of power.A vad stopped alarm was then logged at 22:13:50, indicating that the motor failed to restart after multiple attempts.Seven (7) additional losses of power, four (4) additional vad stopped alarms, and four (4) vad disconnect alarms, indicating physical disconnections of the driveline from the controller, were logged between 22:28:42 and 23:27:41.Analysis of the alarm log file also revealed a power disconnect alarm logged on 23/nov/2018 at 22:38:18 involving (b)(6).During the power disconnect alarm, a safety alert word (saw) value was 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 the additional losses of power to the controller.Log file analysis associated with (b)(6) revealed six (6) controller power-ups without a successful motor start event logged on 23/nov/2018 between 22:25:20 and 23:36:24.Review of the event log file revealed that, prior to the initial power-up event, the controller last had power on 18/dec/2017.Review of the data log file revealed that the controller was not in use prior to the reported event, indicating that the controller power-up event occurred during a control ler exchange.Analysis of the alarm log file revealed three (3) vad stopped alarms due to the failure of the pump to restart after multiple attempts, and four (4) vad disconnect alarms, indicating a physical disconnection of the driveline from the controller logged on 23/nov/2018 between 22:25:27 and 23:36:29.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 a loss of power to the controller, the controller display screen will be blank, and the controller will emit a loud, continuous alarm.As a result, the reported ¿blank screen and high priority alarm¿ and ¿vad would not restart¿ events were confirmed.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 or both power sources.The most likely root cause of the additional controller power-up events can be attribut ed to controller exchanges and troubleshooting of the vad stopped alarms.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller losses of power during pump start due to battery discharge overcurrent condition.A p ossible root cause of the power disconnect alarm may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the vad disconnect alarms can be attributed to physical disconnections of the driveline from the con troller during the controller exchange 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) was not in scope of fca cvg-21-q3-21, which was initiated for pumps with failures to restart.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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.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.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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