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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1104 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503)
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| Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/02/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Additional information has been requested regarding the interventions performed for the event, 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.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0 / model #: 1420 / catalog #: 1420 / expiration date: 31-may-2020 / serial #: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 08-may-2019 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system ¿ controller 2.0 / model #: 1420 / catalog #: 1420 / expiration date: 31-may-2020 / serial #: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 08-may-2019 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2020 / serial #: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 11-dec-2019 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2020 / serial #: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 11-dec-2019 / 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 when the patient was going to bed they noticed that one battery had 25 percent battery life and the other battery had 50 percent battery life.There was no critical battery alarm.When the patient disconnected one battery to switch to the controller ac adapter a ventricular assist device (vad) stop alarm occurred and there was an unexpected loss of power to the controller.The controller was exchanged.The vad restarted after 30 seconds.It was noted that power switching was a possibility.Log file review for the controller in use after the exchange indicated there was also a vad stopped alarm on the new controller and there were 18 restart attempts.There were two instances of the vad failing to restart across the two controllers.The cause of the restart issue was unknown.A vad exchange was being considered.The vad and new controller remain in use.The batteries were replaced.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 received a heart transplant.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information and a correction.B1 corrected from product problem to adverse event and product problem.Additional information is noted in b2, b5, d6b, h6 and h10.Additional products: d4: serial or lot#: (b)(6) h6: imf code(s): f1203, f1903 d4: serial or lot#: (b)(6) h6: imf code(s): f1203, f1903 d4: serial or lot#: (b)(6) h6: imf code(s): f1203, f1903 d4: serial or lot#: (b)(6) h6: imf code(s): f1203, f1903 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 correction.H1: changing type of reportable event to serious injury.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 additional information.The patient was hospitalized, changed: - b1 from product problem to adverse event product problem , - b2: added hospitalization - b5: newly added information - h6 and h10: update all devices codes imf, ime additional products: con406668 h6: patient ime code(s): e2402 h6: imf code(s): f08 con406667 h6: patient ime code(s): e2402 h6: imf code(s): f08 (b)(6) h6: patient ime code(s): e2402 h6: imf code(s): f08 (b)(6) h6: patient ime code(s): e2402 h6: imf code(s): f08 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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Event Description
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It was further reported that two days later, the patient was hospitalized and was listed for an emergent heart transplant.
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Manufacturer Narrative
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### a supplemental report is being submitted for device analysis and investigation completion.Product event summary: the ventricular assist device (vad) ((b)(6)), two (2) controllers ((b)(6) , (b)(6)), and two (2) batteries ((b)(6) , (b)(6)) were not returned for evaluation.Log file analysis revealed that the primary controller in use during the reported event, (b)(6), contained a feature that records whether a power source experienced a communication error or a disconnection within each 15 minute interval.Log file analysis did not reveal any premature power switching events or critical battery alarms logged within the analyzed period.Log file analysis associated with (b)(6)revealed a controller power up event on 02-feb-2022 at 23:56:33.The data point prior to the loss of power revealed that (b)(6) was connected to power port 1 with 25% relative state of charge (rsoc) and (b)(6) was connected to power port 2 with 38% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port 1 and (b)(6) was connected to power port 2.The controller was without power for 12 seconds.No anomalies were observed leading up to the loss of power.Analysis of the alarm log file associated with (b)(6) re vealed a vad stopped alarm logged on (b)(6) 2022 at 23:57:00, indicating that the pump failed to restart after multiple attempts.Additionally, analysis of the alarm log file associated with (b)(6) revealed a vad disconnect alarm was logged on (b)(6) 2022 at 23:58:37 indicating a physical disconnection of the driveline from the controller and additional controller power up events were logged since (b)(6) 2022, likely due to troubleshooting during the reported controller exchange.Log file analysis associated with (b)(6) revealed a controller power up event logged on (b)(6) 2022 at 23:58:49.Additionally, a vad disconnect alarm was then logged at 2:58:57, likely indicating that the driveline was not connected to the controller.Review of the data log file associated with (b)(6) revealed that the controller was not in use prior to the controller power up event; the first data point was logged at 23:59:57 on (b)(6) 2022, indicating that the power up event and vad disconnect alarm occurred during a controller exchange.Analysis of the alarm log file associated with (b)(6) also revealed a vad stopped alarm was logged at 23:59:45, indicating that the pump failed to restart after multiple attempts.This was followed by a successful pump start event logged after 18 attempts on (b)(6) 2022 at 00:00:59.As a result, the reported controller loss of power and vad stop events were confirmed.The reported premature power switching and no sound critical battery alarm events could not be confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa (b)(4) is investigating controller losses of power.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21.Capa (b)(4) is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Possible clinical factors that may have contributed to this event includ e the patient¿s pre-existing history and related comorbidities, 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: controller 2.0 (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d15 controller 2.0 (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 battery (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 battery (b)(6) h3: yes h6: fda method code(s): b15, b17 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 as the codes and investigation summary was revised.Updated additional products: serial# (b)(6), h6:fda result code(s): c19 h6:fda conclusion code(s): d10 serial# (b)(6), h6:fda method code(s): b01, b15 h6:fda result code(s): c19 h6:fda conclusion code(s): d14 serial# (b)(6), h6:fda method code(s): b01, b15 h6:fda result code(s): c19 h6:fda conclusion code(s): d14 serial# (b)(6), h6:fda method code(s): b15, b17 h6:fda result code(s): c19 h6:fda conclusion code(s): d10 updated product event summary: the pump ((b)(6)), one (1) controller ((b)(6)), and two (2) batteries ((b)(6)) were returned for evaluation.One (1) controller ((b)(6)) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned controller and batteries revealed that the devices passed visual examination and functional testing.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Internal pathological report revealed no evidence of thrombus within the device.Dimensional verification revealed that the front preload measurement and front housing disc curvature were found to be deviating from release specifications.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Log file analysis revealed that the primary controller in use during the reported event, (b)(6), contained a feature that records whether a power source experienced a communication error or a disconnection within each 15 minute interval.Log file analysis did not reveal any premature power switching events or critical battery alarms logged within the analyzed period.Log file analysis associated with (b)(6) revealed a controller power up event on 02/feb/2022 at 23:56:33.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 25% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 38% 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 12 seconds.No anomalies were observed leading up to the loss of power.Analysis of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on 02/feb/2022 at 23:57:00, indicating that the pump failed to restart after multiple attempts.Additionally, analysis of the alarm log file associated with (b)(6) revealed a vad disconnect alarm was logged on 02/feb/2022 at 23:58:37 indicating a physical disconnection of the driveline from the controller and additional controller power up events were logged since 02/feb/2022, likely due to troubleshooting during the reported controller exchange.Log file analysis associated with (b)(6) revealed a controller power up event logged on 02/feb/2022 at 23:58:49.Additionally, a vad disconnect alarm was then logged at 23:58:57, likely indicating that the driveline was not connected to the controller.Review of the data log file associated with (b)(6) revealed that the controller was not in use prior to the controller power up event; the first data point was logged at 23:59:25 on 02/feb/2022, indicating that the power up event and vad disconnect alarm occurred during a controller exchange.Analysis of the alarm log file associated with (b)(6) also revealed a vad stopped alarm was logged at 23:59:45, indicating that the pump failed to restart after multiple attempts.This was followed by a successful pump start event logged after 18 attempts on 03/feb/2022 at 00:00:59.As a result, the reported controller loss of power and vad stop events were confirmed.The reported premature power switching and no sound critical battery alarm events could not be confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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 correction is being submitted for inclusion of this event as being in-scope for recall with z-0946-2021.This event was submitted historically and has been deemed in-scope for the field corrective action.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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