|
A supplemental report is being submitted for additional event details.Additional products: d1: heartware ventricular assist system ¿ battery d4: model #: 1650./ catalog #: 1650./ expiration date: 30-nov-2022./ serial or lot#: (b)(6).Udi #: (b)(4).D9: no h4: mfg date: 23-nov-2021.H6: patient time code(s): e2402, e1903, e1905 h6: imf code(s): f0801, f08.H6: img code(s): g02002.H6: fda device code(s): a0705.H6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d21.D1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2022 / serial or lot#: (b)(6).Udi #: (b)(4).D9: no h4: mfg date: 23-nov-2021.H6: patient ime code(s): e2402, e1903, e1905 h6: imf code(s): f0801, f08 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d21 d1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2022 / serial or lot#: (b)(6).Udi #: (b)(4).D9: no h4: mfg date: 23-nov-2021.H6: patient ime code(s): e2402, e1903, e1905 h6: imf code(s): f0801, f08 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d21 d1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2022 / serial or lot#: (b)(6).Udi #: (b)(4).D9: no h4: mfg date: 23-nov-2021 h6: patient ime code(s): e2402, e1903, e1905 h6: imf code(s): f0801, f08 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d21.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.
|
|
A supplemental report is being submitted for device evaluation.Product event summary: the pump, two (2) controllers, and four (4) batteries 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 the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned batteries and (b)(6) revealed that the devices passed visual inspection and functional testing.Visual inspection of (b)(6) revealed contamination within both power ports.Functional testing of (b)(6) revealed that the no power alarm only sounded briefly when both power sources were disconnected from the controller and a controller fault alarm was triggered during functional testing, indicating an issue with the internal battery.Internal inspection revealed that the internal nickel-metal hydride (nimh) battery, which powers the no power alarm, was swollen.After the internal battery was replaced, the controller performed as intended.Supplemental testing was performed on the controller and the test results revealed that the gold-plating of the pins were worn, exposing the base metal.The exposure of the base metal is susceptible to the effects of corrosion.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Internal pathological report revealed evidence of thrombus within the device.Dimensional verification revealed that the front housing disc curvature, rear housing disc curvature, and front preload measurements were found to be deviating from release specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface, this increase in friction was investigated during the capa pr00502194 investigation.Log file analysis revealed that the 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 revealed that (b)(6) was the patient's primary controller.Log file analysis associated with (b)(6) revealed two (2) controller fault alarms were logged 17-may-2022 at: 20:36:15 and on 19-may-2022 at 09:57:00, indicating an issue with the internal battery.In addition, log files revealed that the controller was in use for more than two (2) years.Of note, review of the event log file revealed that the controller fault alarm was permanently silenced on 19-may-2022 at 09:57:00 by the site using a monitor; the audible sound during the connection and disconnection of a power source will also be muted when the controller fault alarm is permanently silenced.Log file analysis associated with (b)(6) then recorded four (4) controller power up events on 02-jun-2022 at 19:00:54, 19:01:19, 19:01:30, and 19:01:40.The data point prior to the losses of power revealed that (b)(6) was connected to power port one (1) with 58% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 22% rsoc.The data point recorded after the losses of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were recorded leading up to initial loss of power.The controller was without power for ten (10) seconds following the initial loss of power.A successful pump start event was logged at 19:01:08.A vad disconnect alarm was logged on 02-jun-2022 at 19:01:09 following the successful pump start event, which was most likely a false alarm, 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.During the pump start event, the data log file recorded high power consumption, which required more current from the battery.Leading up to the losses of power at 19:01:19 and 19:01:30, rev iew of the controller's internal logs revealed safety alert word (saw) values were recorded on the two (2) connected power sources, (b)(6) and (b)(6), indicating overcurrent alerts.It is likely that the overcurrent condition prevented both batteries from providing power, resulting in additional loss of power to the controller.A vad stopped alarm was logged at 19:01:59, due to a failure of the pump to restart after multiple attempts.This was followed an additional vad disconnect logged at 19:34:31 indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting during the reported controller exchange.Analysis of the data log file associated with (b)(6) revealed momentary disconnections between the controller and additional batteries.A momentary disconnection will result in an audible tone.Momentary disconnections occurred during the reported event and are related to the reported "battery noise" event log file analysis associated with (b)(6) revealed a controller power up event logged on 02-jun-2022 at 20:30:55, indicating that the controller was put into use following a controller exchange.A vad disconnect alarm was then logged on 02-jun-2022 at 20:31:01, likely due to the controller being powered up without the driveline connected.A vad stopped alarm was logged on 02-jun-2022 at 20:32:02 due to a failure of the pump to restart after multiple attempts.This was followed by one (1) additional controller power up event, three (3) additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts, and two (2) additional vad disconnect alarms indicating a physical disconnection of the driveline from the controller, logged on 02-jun-2022 since 20:35:22 likely due to the reported troubleshooting of the alarms.In addition, log files revealed speed parameters between 0 and 500 rpm during the period in which the pump was attempting to restart.As a result, the reported controller fault alarm, loss of power, vad stop, fluctuating speed associated with high power, controller no sound, and "battery noise" events were confirmed.The reported controller drop events could not be confirmed due to insufficient evidence.A power source lubrication procedure had been performed on some associated batteries in accordance with the requirements under fsca cvg-18-q4-19 on 01-oct-2018 and 20-dec-2018.Some associated batteries were released prior release.A possible cause of the reported controller drop event can be attributed to the handling of the device.The most likely root cause of the reported controller no sound event can be attributed the controller fault alarm being permanently silenced by the site using a monitor.The most likely root cause of the controller fault alarm event can be attributed to a reduced charge capacity of the internal nimh battery.Capa pr00492825 was opened to investigate internal battery issues with controller 2.0.The most likely root cause of the reported ¿noise of the batteries¿ event can be attributed to momentary disconnections due to contamination within the power ports and/or due to temporary corrosion of the controller-port/power-source pins.The most likely root cause of the observed contamination within the power ports event can be attributed to handling of the device.A possible root cause of the initial 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.Capa pr00544941 is investigating controller losses of power due to battery discharge overcurrent conditions during pump start attempts.Possible causes of the observed vad disconnect alarms can be attributed to a loss of synchronization of commutation leading to a false vad disconnect alarm, and/or a physical disconnections of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.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: d4: serial or lot#: (b)(6), d9: yes, return date:05-jul-2022 h3: yes dev rtn to mfr? yes h6: img code(s): g02002, g0200701, g04034, g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c19, c02, c020701, c04, c06, c15, c21 h6: fda conclusion code(s): d10, d02, d11, d1105, d15, d16 d4: serial or lot#: (b)(6), d9: yes, return date: 05-jul-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d4: serial or lot#: (b)(6), d9: yes, return date: 05-jul-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial or lot#: (b)(6), d9: yes, return date: 05-jul-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial or lot#: (b)(6), d9: yes, return date: 05-jul-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial or lot#: (b)(6), d9: yes, return date: 05-jul-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 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.
|
