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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Pumping Stopped (1503); Increase in Suction (1604); Obstruction of Flow (2423); Pumping Problem (3016)
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| Patient Problems
Intracranial Hemorrhage (1891); Nausea (1970); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)
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| Event Date 04/21/2022 |
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Event Type
Injury
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Event Description
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It was reported that the patient was admitted with nausea and vomiting and the ventricular assist device (vad) exhibited a sudden decrease of flow and an inflow thrombus was suspected.It was also reported that the vad exhibited below normal power and suction and low flow alarms.A computerized tomography (ct) scan was performed that did not show evidence of outflow graft obstructions, but the scan was not clear due to artifacts.It was also reported that the patient experienced a hemorrhagic stroke and received a brain/head ct scan and their subtherapeutic international normalized ratio (inr) goal was decreased.The patient's lactate dehydrogenase (ldh) is normally in the 170's and was elevated to 353 and their plasma free hemoglobin (hgb) was elevated from 15-16 to 66.Their urine was clear and all other labs were within normal limits.Despite receiving fluid and inotropes, the flows did not increase.The vad remains in use.No further patient complications have been reported as a result of this event.
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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.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 additional information has being received for this event.Updated section: b5 desc evt problem h6:fda device code 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 during the pump exchange due likely to thrombus the vad stopped in the operating room.
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Event Description
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It was further reported that during the pump exchange due likely to thrombus the controller exhibited a vad stop alarm and the pump stopped in the operating room.
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Manufacturer Narrative
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A supplemental report is being submitted for a correction: corrected section: b5 desc evt problem d9 device available for evaluation and return date h3 device evaluation corrected additional product: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420/ expiration date: 30-nov-2019/ serial or lot#: (b)(6) udi #: (b)(4) d9: yes h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 27-nov-2018 h5: no h6: patient ime code(s): e0514, e0118, e0139, e1020, e2204 h6: patient imf code(s):f1203, f08, f1903, f2203, f23, f2303 h6: patient img code(s):g04035 h6:fda device code(s): a141204 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 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 vad was explanted.
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Manufacturer Narrative
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### a supplemental report is being submitted for corrections.The prior supplemental regulatory report stated on it that the vad was schedule to be exchange.The event description has been updated to state that the vad was explanted.The explant date and annex f code has been updated.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 event details.The event description has been updated with the additional information additional information has been requested regarding the [reason for ai] of 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.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 the patient presented with elevate powers and flows.The vad exhibited power consumption above normal limits, more suctions alarms and high watts alarms.The patient's ldh had elevated above 1000 and the vad was scheduled to be exchanged.
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Event Description
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It was further reported that a battery was returned to the manufacturer along with the ventricular assist device (vad).The battery 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 device analysis and investigation completion.Product event summary: the ventricular assist device (vad), controller, and a battery 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.No performance allegations were made against (b)(6).A review of the pump¿s manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of (b)(6) revealed that the device passed visual inspection.Functional testing revealed abnormalities related to the relative state of charge (rsoc); the battery was not estimating the capacity accurately.This is an additional observation not related to the reported event, likely attributed to an estimation error.Failure analysis of the controller revealed that the device passed functional testing.Visual inspection revealed contamination within both power ports of the controller.This is an additional finding not related to the reported event, likely due to handling of the device.Failure analysis of the returned vad revealed that the device passed functional testing.Visual examination revealed abrasions on the lower housing ceramic surface and on the inferior surface of the impeller.These friction marks are indicative that an external factor may have f orced the impeller against the rear housing with sufficient strength to overcome the rear preload of the magnetic spring/suspension system, thus leading to scoring marks observed during visual inspection.Dimensional verification revealed that the front and rear housing disc curvatures were found to be deviating from 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.Internal pathological report revealed evidence of thrombus within the device.Log file analysis associated with the controller revealed a sudden decrease in power consumption and estimated flow beginning on 21-apr-2022 to parameters below normal operating range, followed by subsequent increase in power and flow on 22-apr-2022.Two (2) increases in power consumption and estimated flows were logged between 23-apr-2022 and 05-may-2022 leading to parameters above the normal operating range, each followed by subsequent decreases in power consumption and estimated flows.An additional sustained increase in power consumption and estimated flows was observed beginning on 05-may-2022 leading to parameters above the normal operating range.Analysis of the alarm log file associated with the controller revealed one (1) low flow alarm and two (2) suction alarms logged since 21-apr-2022 and fourteen (14) high watt alarms have been logged since 02-may-2022.Analysis of the alarm log file associated with the controller also revealed one (1) vad stopped alarm, one electrical fault alarm, and one (1) vad disconnect alarm were logged on 06-may-2022.The vad stopped alarm was logged at 13:31:18, indicating a failure of the motor stators failed.An electrical fault alarm was recorded at 13:31:19 due to an overcurrent condition on the front stator, which resulted in the stators failing.In addition, review of the event log file revealed a reactivation event logged on 06-may-2022 at 13:31:18 due to an overcurrent condition in the rear stator.A vad stopped alarm was simultaneously logged indicating that the motor stators failed.An electrical fault alarm was then logged at 13:31:19 due to an overcurrent condition on the front stator.The vad disconnect alarm was logged at 13:31:19 indicating a physical dis connection of the driveline from the controller, likely due to troubleshooting during the reported pump exchange.Post-explant functional analysis revealed that the vad met pre-implant requirements with power average consumption of 1.98 watts.Dimensional verification revealed that the front and rear housing disc curvatures were found to be deviating from release specifications.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface.Visual examination revealed abrasions on the lower housing ceramic surface and on the inferior surface of the impeller.These friction marks are indicative that an external factor may have forced the impeller against the rear housing with sufficient strength to overcome the rear preload of the magnetic spring/suspension system, thus leading to scoring marks observed during visual inspection.Internal pathology report revealed evidence of thrombus within the pump.As a result, the reported suction, low power, low flow, high power, device thrombus, and vad stop events were confirmed.Information received from the site indicated that the patient was admitted with nausea and vomiting, and the vad thrombus was suspected.It was also reported that the patient experienced a hemorrhagic stroke and received a brain/head c t scan, and their subtherapeutic international normalized ratio (inr) goal was decreased.The patient's lactate dehydrogenase (ldh) and plasma free hemoglobin (hgb) were elevated.The patient was treated with fluid and inotropes.It was further reported the vad was explanted due to thrombus.Based on the available information, the device may have caused or contributed to the reported event.Based on the available information, the most likely root cause of the reported low power, low flow, and suction event can be attributed to thrombus at the inflow cannula.Based on the available information the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Based on risk documentation and the available information, a possible root cause of the reported vad stopped alarm, observed reactivation event, and observed electrical fault alarm can be attributed, but not limited, to driveline wire damage, a marginal connection between the driveline and the controller, and/or contamination within the driveline connector.Per the instructions for use, device thrombosis and neurological dysfunction are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse events.Possible clinical factors that may have contributed to this event include 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: img code(s): g04034 h6: fda method code(s): b15, b01 h6: fda results code(s): c04, c15 h6: fda conclusion code(s): d15, d11 d1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 31-mar-2022 / serial #: (b)(6), udi #: (b)(4), d9: yes, return date: 13-may-2022 h3: yes dev rtn to mfr? yes h4: mfg date: 31-mar-2021 h5: no h6: patient ime code(s): e0514, e0118, e0139, e1020, e2204 h6: imf code(s): f1203, f08, f1903, f23, f2203, f2303 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b15, b01 h6: fda results code(s): c10 h6: fda conclusion code(s): d02 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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