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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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/01/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system -controller 2.0 model #: 1420 / catalog #: 1420 / expiration date: 13-aug-2018 / 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: 27-sep-2017 labeled for single use: no (b)(4).Heartware ventricular assist system -controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2021/ 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: 23-nov-2020 labeled for single use: no (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 ventricular assist device (vad) would not restart after the controller was being exchanged due to having internal battery problem.There were several attempts to restart the vad, and again swap to the primary controller and the vad would not restart still.The patient was hospitalized in the intensive care unit (icu) and remains stable with the vad still stopped and no interventions.The vad remains in the patient and the controllers have been removed from service.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 vad and one of the controllers were exchanged.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Outcomes attributed to adverse event, describe event or problem, device available for evaluation, device evaluated by manufacturer?, and additional manufacturer narrative were updated.Additional products: d1: heartware ventricular assist system -controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 13-aug-2018 / serial (b)(6) dev rtn to mfr? yes h3: no, device evaluation anticipated, but not yet begun h6: imf code(s): f0801, f26, f12, f08, f1203, f1901, f1905 d1: heartware ventricular assist system -controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2021/ serial #:(b)(6),h6: imf code(s): f0801, f26, f12, f08, f1203, f1901, f1905 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 corrections to: additional codes: from f26 and f12 to only f12 additional products: con311044 h6: from imf code(s): f0801, f26, f12, f08 to f0801, f12 and f08 (removed f12) h6: from img code(s): g04035 to g04035 and g02002 con413471 h6: from imf code(s): f0801, f26, f12, f08 to f0801, f12 and f08 (removed f12) h6: from img code(s): g04035 to g04035 and g02002 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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Manufacturer Narrative
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A supplemental report is being submitted for correction to b5 to add additional details.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 the ventricular assist device (vad) stop occurred during prophylactic/elective replacement of the controller as to avoid issues with a controller exchange in the home setting.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) (b)(6) was returned for evaluation.(b)(6) was not returned for evaluation.(b)(6) was lost in transit and not available for evaluation; an internal investigation was initiated to investigate this issue.A review of the pump¿s manufacturing documentation confirmed that the associated device 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 pump revealed that the device passed visual examination.Post-explant functional analysis on the returned pump was not possible since the driveline was too short to be able to splice the driveline and then conduct functional testing.Dimensional verification revealed that the rear housing disc curvature and front housing disc curvature were found to be deviating from specifications.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface.These deviations are being investigated under capa pr00532915.Log file analysis revealed that (b)(6) was the patient¿s primary controller, initially in use at the time of the reported event.Review of the log files associated with (b)(6) revealed a vad disco nnect alarm on (b)(6) 2021 at 07:46:49, indicating a physical disconnection of the driveline from the controller, which corresponds with the reported prophylactic controller exchange.A controller power-up event was then recorded at 07:47:43 followed by a vad stopped alarm at 07:48:05 due to a failure of the pump to restart after several attempts.This was followed by additional controller power-up events, likely due to troubleshooting.A controller power-up event was logged on (b)(6) at 09:04:29, followed by initial set up of the controller, including programming of the time/date, patient id, pump id, and speed.A vad stopped alarm was then recorded at 09:08:56 due to a failure of the pump to restart after several attempts.This was followed by a vad disconnect alarm in addition to several additional controller power-up events and vad stopped alarms due to failures of the pump to restart.Of note, the setting of the time on (b)(6) may have impacted the recorded sequence of events; based on the reported event details, it is possible that the failure to restart first occurred on (b)(6).As a result, the reported failure of the pump to restart event was confirmed.Log file analysis also revealed consistent power consumption above normal operating range within the analyzed period.This is an additional observation not related to the reported event.Based on the risk documentation, possible causes of the observed high power event may be attributed to multiple factors including but not limited to external factors such as thrombus formation/ingestion, inappropriate pump rotational speed, and/or patient related factors.The most likely root cause of the vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller 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 failures 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.Additional products: d4: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 additional products: d4: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 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.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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