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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1420 |
| Device Problems
Pumping Problem (3016); Appropriate Term/Code Not Available (3191); Data Problem (3196)
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| Patient Problems
No Known Impact Or Consequence To Patient (2692); Heart Failure/Congestive Heart Failure (4446)
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| Event Date 03/02/2020 |
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Event Type
Death
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Additional information has been requested regarding the further information 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.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 the ventricular assist device (vad) exhibited low flows on the controller.Echocardiogram, computerized tomography (ct) with contrast, card lab with contrast, and lab tests were performed and did not give any signs or indication of any suspicious high clinical parameters.The vad flow continued to fall and further imaging was done.Later the vad was stopped for two minutes for imaging, no signs of occlusion or artifact and when the vad restarted the flow was normal for a minute then dropped again.The controller was exchanged and flow was normal then dropped, when the physician went to adjust the low flow alarm the flow increased and stabilized.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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A supplemental is being submitted for investigation completion.Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported low flow event was confirmed via log file analysis which revealed a sustained decrease in power consumption and estimated flows starting on 01-mar-2020, leading to parameters below the normal operating range, and 63 low flow alarms recorded since 07-mar-2020.Visual inspection of the controller revealed contamination within power ports one (1) and two (2).This is an additional observation not related to the reported event, likely due to handling of the device.A visual inspection under 10x magnification also revealed hairline cracks around power ports one (1) and two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an investigation, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Furthermore, internal inspection revealed a crack on a standoff post within the controller housing.The observed crack on the standoff post was not related to the reported event.Based on an investigation, the root cause of the crack was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming into contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.Internal evaluation was opened to investigate cracks on the internal threaded posts with controller 2.0.Functional testing of the returned controller revealed that a controller fault alarm was triggered during bench testing, indicating a fault regarding the internal nickel-metal hydride (nimh) battery that powers the ¿no power¿ alarm.Supplemental testing revealed that the internal nimh battery was swollen and the cells of nimh battery had voltage levels below what was expected.After the internal battery was replaced, the controller performed as intended.The controller fault alarm triggered during testing is an additional finding not related to the reported event, which can be attributed to a faulty internal nimh battery.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling.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 device evaluation.Product event summary: the controller was returned for evaluation.The ventricular assist device (vad) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Visual inspection of the controller revealed contamination within power ports one (1) and two (2).This is an additional observation not related to the reported event, likely due to handling of the device.Additionally, visual inspection under 10x magnification revealed hairline cracks around power ports one (1) and two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an investigation conducted under an internal investigation, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Even though this investigation is closed, the controller falls within the bounds of this investigation.Furthermore, internal inspection revealed a crack on a standoff post within the controller housing.The observed crack on the standoff post was not related to the reported event.Based on an investigation, the root cause of the crack was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming into contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.An internal investigation was opened to investigate cracks on the internal threaded posts with controller 2.0.Functional testing of the returned controller revealed that a controller fault alarm was triggered during bench testing, indicating an issue regarding the internal nickel-metal hydride (nimh) battery that powers the ¿no power¿ alarm.Supplemental testing revealed that the internal nimh battery was swollen.After the internal battery was replaced, the controller performed as intended.In addition, log files revealed that the controller was in use for more than two (2) years.The controller fault alarm triggered during testing is an additional finding not related to the reported event, which can be attributed to a reduced charge capacity of the internal nimh battery.An internal investigation was opened to evaluate internal battery issues with controller 2.0.The reported low flow event was confirmed via log file analysis which revealed a sustained decrease in power consumption and estimated flows starting on (b)(6) 2020, leading to parameters below the normal operating range, and 63 low flow alarms recorded since (b)(6) 2020.Information received from the site indicated that several echocardiograms, a computerized tomography (ct) scan with contrast, and cardiac laboratory tests with contrast were performed.However, results did not give any signs of thrombus, infection, or any ¿suspicious high¿ clinical parameters; the conclusion was right heart failure.The patient later received another cardiac lab check with contrast which indicated there was not an occlusion or artifact.Based on the available information, there is no evidence to suggest that a device malfunction caused or contributed to the reported low flow event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, and/or constriction at the outflow graft.Per the instructions for use, right ventricular failure is a known potential complication associated with the implantation of a vad.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, issu es related to the therapeutic use of anti coagulant 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: 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, d12.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.
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Manufacturer Narrative
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Corrections: b1, b2, b5, b7, d4, d10, e1, h6, h10.A supplemental report is being submitted for corrections.B1 corrected from product problem to adverse event & product problem.B2 outcome attributed to adverse event corrected to intervention required, hospitalization.B5 description of event problem corrected from 'it was reported that the ventricular assist device (vad) exhibited low flows on the controller.Echocardiogram, computerized tomography (ct) with contrast, card lab with contrast, and lab tests were performed and did not give any signs or indication of any suspicious high clinical parameters.The vad flow continued to fall and further imaging was done.Later the vad was stopped for two minutes for imaging, no signs of occlusion or artifact and when the vad restarted the flow was normal for a minute then dropped again.The controller was exchanged and flow was normal then dropped, when the physician went to adjust the low flow alarm the flow increased and stabilized.The vad remains in use.No further patient complications have been reported as a result of this event.' to 'it was reported that the patient was admitted to the intensive care unit (icu) due to the ventricular assist device (vad) exhibiting below normal power consumption and decreasing flow associated with low flow alarms.Several echocardiograms, a computerized tomography (ct) scan with contrast and cardiac laboratory tests with contrast were performed that did not give any signs of thrombus, infection or any ¿suspicious high¿ clinical parameters.The conclusion was right heart failure.The vad flow dropped down to approximately one l/min.The following day, the patient received a cardiac lab check with contrast and a vad inflow or outflow occlusion was suspected.The clinical results of all examinations indicated there was not an occlusion or artifact.The patient was supported by inotropes and the vad exhibited 1.5 l/min.A vad exchange was not a solution as the patient would not have been able to survive surgery.While the patient was being examined in the cardiac lab with contrast, the vad was turned off for two minutes.After turning the vad off, the contrast was checked and there were no signs of occlusion or artifact.When the vad was turned on, the flow jumped straight up to four l/min and within a minute, the vad flow dropped to 1.5 l/min.When the patient arrived in the icu, a controller exchange was performed.The vad flow went straight up to 4.5 l/min and then quickly dropped to 1.5 l/min and the vad exhibited a low flow alarm.The vad flow went straight up to four l/min and stabilized.The following day, the vad exhibited steady flow between 4 - 4.5 l/min.The vad remains in use.Nofurther patient complications have been reported as a result of this event.' b7 relevant history corrected from heart failure, bypass, ablation, brain infarction to severe heart failure, bypass, ablation, brain infarction.D4 unique identifier (udi) # corrected from asku to (b)(4).D10 concomitant product corrected to remove 1104 vad implanted (b)(6) 2017.E1 facility name corrected from (b)(6), street 1 corrected from (b)(6), city corrected from (b)(6).H6 patient codes corrected from c76143 to e0611 and device codes corrected from c64343 to a1107, a1412.H10 corrected to include additional product.Additional products: d1: heartware ventricular assist system ¿ pump d4: model #: 1104 / catalog #: 1104 / expiration date: 31-mar-2019 / serial #: (b)(6) udi #: asku d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 31-mar-2017 h5: yes h6: patient ime code(s): e0611 h6: imf code(s): f12, f22, f0801, f2203, f2303 h6: fda device code(s): a1412 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 reported that the patient was admitted to the intensive care unit (icu) due to the ventricular assist device (vad) exhibiting below normal power consumption and decreasing flow associated with low flow alarms.Several echocardiograms, a computerized tomography (ct) scan with contrast and cardiac laboratory tests with contrast were performed that did not give any signs of thrombus, infection or any ¿suspicious high¿ clinical parameters.The conclusion was right heart failure.The vad flow dropped down to approximately one l/min.The following day, the patient received a cardiac lab check with contrast and a vad inflow or outflow occlusion was suspected.The clinical results of all examinations indicated there was not an occlusion or artifact.The patient was supported by inotropes and the vad exhibited 1.5 l/min.A vad exchange was not a solution as the patient would not have been able to survive surgery.While the patient was being examined in the cardiac lab with contrast, the vad was turned off for two minutes.After turning the vad off, the contrast was checked and there were no signs of occlusion or artifact.When the vad was turned on, the flow jumped straight up to four l/min and within a minute, the vad flow dropped to 1.5 l/min.When the patient arrived in the icu, a controller exchange was performed.The vad flow went straight up to 4.5 l/min and then quickly dropped to 1.5 l/min and the vad exhibited a low flow alarm.The vad flow went straight up to four l/min and stabilized.The following day, the vad exhibited steady flow between 4 - 4.5 l/min.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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A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury additional codes: imf code was updated to f08 this regulatory report is being submitted as part of a retrospective review and remediation per (b)(6) due to an fda audit observation.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 reported that the ventricular assist device (vad) exhibited low flows on the controller.Echocardiogram, computerized tomography (ct) with contrast, card lab with contrast, and lab tests were performed and did not give any signs or indication of any suspicious high clinical parameters.The vad flow continued to fall and further imaging was done.Later the vad was stopped for two minutes for imaging, no signs of occlusion or artifact and when the vad restarted the flow was normal for a minute then dropped again.The controller was exchanged and flow was normal then dropped, when the physician went to adjust the low flow alarm the flow increased and stabilized.It was reported that the patient was admitted to the intensive care unit (icu) due to the ventricular assist device (vad) exhibiting below normal power consumption and decreasing flow associated with low flow alarms.Several echocardiograms, a computerized tomography (ct) scan with contrast and cardiac laboratory tests with contrast were performed that did not give any signs of thrombus, infection or any ¿suspicious high¿ clinical parameters.The conclusion was right heart failure.The vad flow dropped downto approximately one l/min.The following day, the patient received a cardiac lab check with contrast and a vad inflow or outflow occlusion was suspected.The clinical results of all examinations indicated there was not an occlusion or artifact.The patient was supported by inotropes and the vad exhibited 1.5 l/min.A vad exchange was not a solution as the patient would not have been able to survive surgery.While the patient was being examined in the cardiac lab with contrast, the vad was turned off for two minutes.After turning the vad off, the contrast was checked and there were no signs of occlusion or artifact.When the vad was turned on, the flow jumped straight up to four l/min and within a minute, the vad flow dropped to 1.5 l/min.When the patient arrived in the icu, a controller exchange was performed.The vad flow went straight up to 4.5 l/min and then quickly dropped to 1.5 l/min and the vad exh ibited a low flow alarm.The vad flow went straight up to four l/min and stabilized.The following day, the vad exhibited steady flow between 4 - 4.5 l/min.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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This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: the controller ((b)(6)) was returned for evaluation.The ventricular assist device (vad) ((b)(6)) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Visual inspection of the controller revealed contamination within power ports one (1) and two (2).This is an additional observation not related to the reported event, likely due to handling of the device.Additionally, visual inspection under 10x magnification revealed hairline cracks around power ports one (1) and two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an investigation conducted under capa pr00381374, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Even though this capa is closed, (b)(6) falls within the bounds of this capa.Furthermore, internal inspection revealed a crack on a standoff post within the controller housing.The observed crack on the standoff post was not related to the reported event.Based on an investigation, the root cause of the crack was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming into contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.Capa pr00450834 was opened to investigate cracks on the internal threaded posts with controller 2.0.Functional testing of the returned controller revealed that a controller fault alarm was triggered during bench testing, indicating an issue regarding the internal nickel-metal hydride (nimh) battery that powers the ¿no power¿ alarm.Supplemental testing revealed that the internal nimh battery was swollen.After the internal battery was replaced, the controller performed as intended.In addition, log files revealed that the controller was in use for more than two (2) years.The controller fault alarm triggered during testing is an additional finding not related to the reported event, which 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 reported low flow event was confirmed via log file analysis which revealed a sustained decrease in power consumption and estimated flows starting on 01-mar-2020, leading to parameters below the normal operating range, and 63 low flow alarms recorded since 07-mar-2020.The reported flow estimation error event could not be confirmed.Information received from the site indicated that several echocardiograms, a computerized tomography (ct) scan with contrast, and cardiac laboratory tests with contrast were performed.However, results did not give any signs of thrombus, infection, or any ¿suspicious high¿ clinical parameters; the conclusion was right heart failure.The patient later received another cardiac lab check with contrast which indicated there was not an occlusion or artifact.It was further reported that the patient required hospitalization and was later moved to the intensive care unit (icu).During the hospitalization, the patient passed away due to severe comorbidity.Of note, the patient was said to be elderly.Based on the available information, the device may have caused or contributed to the reported low flow event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, and/or constriction at the outflow graft.Per the instructions for use, right ventricular failure and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of right ventricular failure.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 anti coagulant 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.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 required hospitalization and was later moved to the intensive care unit (icu).During the hospitalization, the patient passed away due to severe comorbidity.Of note, the patient was said to be elderly.
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