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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Display or Visual Feedback Problem (1184); Failure to Pump (1502); Pumping Stopped (1503); Battery Problem (2885); Power Problem (3010); Pumping Problem (3016)
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| Patient Problems
Chest Pain (1776); Nausea (1970); Anxiety (2328); Heart Failure/Congestive Heart Failure (4446)
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| Event Date 02/24/2021 |
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Event Type
Death
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Manufacturer Narrative
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Concomitant medical products: 5568-53 lead implanted (b)(6)2006; 429688 lead, 6935m62 lead implanted (b)(6) 2013.Additional products: heartware ventricular assist system controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2021 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021.No, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 17-jun-2020.Labeled for single use: no.(b)(4).(b)(4).Heartware ventricular assist system controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2021 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021.No, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 17-jun-2020.Labeled for single use: no.(b)(4).(b)(4).Heartware ventricular assist system controller ac adapter.Model #: 1430 / catalog #: 1430 / expiration date: 27-apr-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021.No, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 27-apr-2018.Labeled for single use: no.Labeled for single use: no.(b)(4).Heartware ventricular assist system controller ac adapter.Model #: 1430 / catalog #: 1430 / expiration date: 27-apr-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes mfg date: 27-apr-2018.Labeled for single use: no.(b)(4).Heartware ventricular assist system battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 16-may-2018.(b)(4).(b)(4).Heartware ventricular assist system battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021 no, device evaluation (b)(4).Heartware ventricular assist system battery.Model #: 1650 / catalog #: 1650 / expiration date: 30-jun-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 02-jun-2018.Labeled for single use: no.(b)(4).Heartware ventricular assist system battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 16-may-2018.Labeled for single use: no.(b)(4).B)(4).Heartware ventricular assist system battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 07-may-2018.Labeled for single use: no.(b)(4).(b)(4).Additional information has been requested regarding the vad implant date, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Investigation of this event is pending and a supplemental report will be sent upon its completion.
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Event Description
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It was reported that the patient was admitted for a prophylactic controller exchange and they were asymptomatic.The patient did not want a vad exchange if the vad was not able to restart and they requested to be do not resuscitate (dnr)/do not intubate (dni).Following the exchange to a new primary controller, the controller turned on and the ventricular assist device (vad) exhibited greater than 25 watts, flow greater than 10 liters and speed fluctuating between zero and 700 or so rpms with a maximum of 1100 rpm.Multiple attempts were made to cycle power to the controller and the new primary controller was subsequently exchanged with a new backup controller.The new primary controller and new backup controller were exchanged frequently and exhibited unexpected losses of power.The vad exhibited multiple vad stopped alarms, and one of the controllers exhibited a blank screen and loud continuous tone alarm as if there had been a double power source disconnection despite power being connected.Power source exchanges with the five batteries and two controller ac (ac) adapters were attempted and the issue resolved.One of the batteries exhibited a communication error associated with a power disconnect alarm.The ventricular assist device (vad) did not restart and following a consensus that controller exchanges and vad restart attempts had been exhausted, the vad driveline was disconnected.The patient subsequently experienced nausea, chest pain and worsening heart failure.Once the vad was unable to restart, the patient received dobutamine, oxygen via nasal cannula, and intravenous (iv) morphine and a nitroglycerine drip.It was noted that the plan was to continue inotropes and initiatehospice care.The vad remains implanted but out of service.No further 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 event details and date of device implant.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 expired.
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Manufacturer Narrative
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This supplemental is based solely on the receipt of a maude report.Section f has been updated to reflect that report.Maude database report number: (b)(4).F1: user facility: f2 uf/importer report number: f3: user facility name/address: (b)(6); f4: contact person: (b)(6); f6: date user facility became aware of the event: f7: type of report: initial f8: date of this report: apr-2021; f9: approximate age of device:2 years; f10: event problem codes: f11 report sent to fda: f12: location where event occurred: hospital; patient room; f13: report sent to manufacturer: unknown; f14: manufacturer name and address mfr.Name: medtronic, plc addl: 14400 nw 60th ave city: miami lakes state: fl zip: 33014.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.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation product event summary: the pump (b)(6) was not returned for evaluation.Four (4) controllers (b)(6), five (5) batteries (b)(6), and two (2) controller ac adapters (b)(6) were returned for evaluation.No performance allegations were made against (b)(6).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 devices revealed that the units passed visual inspection and functional testing.Log file analysis revealed that the controllers contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use at the time of the event.Analysis of the alarm log file associated with (b)(6) revealed a vad disconnect alarm logged on (b)(6) 2021 at 15:49:30, indicating a physical disconnection of the driveline from the controller, likely due to the reported controller exchange.Log file analysis revealed that (b)(6) was then in use.Review of the log files associated with (b)(6) revealed several controller power-up events on (b)(6) 2021 between 16:02:40 and 16:04:05 without an associated motor start event.During the attempted motor starts, the data log file recorded high power consumption, which required more current from the batteries.Leading up to the loss of power at 16:03:43, safety alert word (saw) values were recorded on the two (2) connected power sources, (b)(6), indicating overcurrent alerts.It is likely that the overcurrent condition prevented both batteries from providing power, resulting in a loss of power to the controller.A loss of power will result in a blank controller display and a loud, continuous alarm will sound.Two (2) controller power-up events were then logged on (b)(6) at 16:04:13 and 16:05:01, followed by a power disconnect alarm at 16:05:30 involving (b)(6).During the power disconnect alarm, a saw value was recorded indicating an overcurrent alert associated with the high power consumption which required more current from the batteries.The battery was most likely physically disconnected shortly after, causing the controller to log this event as a power disconnect alarm.A vad stopped alarm was logged at 16:06:10, indicating that the pump failed to restart after multiple attempts.Several additional controller power-up events and vad stopped alarms due to failures of the pump to restart, as well as vad disconnect alarms indicting physical disconnections of the driveline from the controllers, were logged on (b)(6) between 16:06:38 and 16:14:01, likely during troubleshooting.In addition, log file analysis revealed speed parameters between 0 and 800 rpm and power consumption above 25w during the period in which the pump was attempting to restart.Log file analysis did not reveal any communication errors logged within the analyzed period.Log file analysis revealed that (b)(6) was not in use during the reported event and was most likely a backup controller.As a result, the reported failure to restart, high power, fluctuating speed, vad stopped alarms, losses of power, and power disconnect alarm events were confirmed.The reported communication error event could not be confirmed.A possible root cause of the reported power disconnect alarm may be attributed, but not limited, to a physical disconnection of the power source.Capa pr00544941 is investigating controller losses of power due to battery discharge overcurrent conditions during pump start attempts.Based on the available information, the most likely root cause of the remaining controller power-up events can be attributed to troubleshooting of the controllers during the reported controller exchanges.The most likely root cause of the vad disconnect alarms can be attributed to the physical disconnection of the driveline from the controller, likely during the reported controller exchanges and/or troubleshooting.The most likely root cause of the vad stopped alarms, high pump power consumption, and low recorded speed can be attributed to failures of the pump to restart after multiple attempts.(b)(6) is part of fca cvg-21-q3-21.Capa pr00502194 is investigating pump failures to restart.Additional products: (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c21, c21 h6: fda conclusion code(s): d16, d10 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 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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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Additional information was received regarding the description of the event problem.Additional products: d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201, d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201, d4: serial or lot#:(b)(6), h6: patient ime code(s): e020201 d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201 d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201, d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201, d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201, d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201, d4: serial or lot#: (b)(6), h6: patient ime code(s): e020201 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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Event Description
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It was further reported that the patient experienced "pain and suffering" as well as "mental anxiety and anguish" as a result of the event.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.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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