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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Power Problem (3010); Pumping Problem (3016)
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| Patient Problems
Bacterial Infection (1735); Headache (1880); Intracranial Hemorrhage (1891); Sepsis (2067); Blurred Vision (2137); Thrombosis/Thrombus (4440); Eye Pain (4467)
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| Event Date 05/05/2022 |
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Event Type
Injury
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Event Description
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It was reported that the ventricular assist device (vad) patient presented to the hospital with acute onset severe right sided headache with radiation of pain behind the eye associated with blurry vision.The patient stated that the pain was progressive and worsening over the past one day.Patient international normalized ratio (inr) prior to admission had been supra and subtherapeutic many times.A head computerized tomography (ct) scan was performed and revealed in a right subarachnoid hemorrhage.It was further reported that an arteria line insertion was performed, and the patient was transferred to another hospital.While in the hospital the patient developed sepsis on the intravenous catheter due to bacteremia found with vegetation on icd lead.The implantable cardioverter defibrillator (icd) leads, and icd generator were successfully removed.It was also reported that the vad exhibited low flow alarms and power consumption below normal range along with the controller exhibiting unexpected loss of power alarms.It was further reported that thrombus was suspected possibly in the inflow cannula, and a performed echocardiogram transthoracic (tte) ct scan revealed aortic valve opening every beat (previously closed) even at higher speeds.Of note, the patient¿s lactate dehydrogenase (ldh) was in the 300s, and anticoagulant medication was administered to the patient.The controller was removed from service, the vad was exchange for the competitor¿s brand and a small piece of the outflow graft was left in the patient.Of note, a small thrombus in the inflow cannula by the rotor was seen after explant.
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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: brand name: heartware ventricular assist system ¿ controller 2.0, model#: 1420 / catalog#: 1420 / expiration date: 31-dec-2019/ 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: 17-dec-2018.Labeled for single use: no.(b)(4).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 an update to: -b5.Desc evt problem 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 patient tolerated the vad exchange well and was discharged home.It was also reported that the flows were between 0.4-0.8l/min on the vad.
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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.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 patient had increasing ldh levels even with treatment.
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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.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 a transthoracic echocardiogram (tte) was performed to exclude endocarditis and that a redo sternotomy was performed with extensive adhesiolysis and the patient was treated with intravenous (iv) antibiotics.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Additional products: serial# (b)(6), h6:fda method code(s): b15, b01 h6:fda result code(s): c15 h6:fda conclusion code(s): d11, d15 serial# (b)(6), h6:fda method code(s): b01 h6:fda result code(s): c19 h6:fda conclusion code(s): d14 product event summary: the ventricular assist device (vad) (b)(6), a segment of the associated outflow graft ((b)(6)), and the controller ((b)(6)) were returned for evaluation.No performance allegations were made against the outflow graft.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 segment of the outflow graft revealed that the device passed visual examination.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front preload measurement, front housing disc curvature, and rear housing disc curvature were found to be deviating from specifications.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 pump.There was no evidence of thrombus within the returned segment of the outflow graft.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection of the returned controller revealed contamination within both power ports, the serial port, and the pump connector; these are additional observations not related to the reported event, likely due to the handling of the device.Log file analysis revealed a sudden decrease in power consumption and estimated f lows to parameters below the normal operating range starting on 21/may/2022 and sixty (60) low flow alarms logged since 21/may/2022.Review of the controller log files also revealed a controller power-up event, with an associated motor start event, logged on 09/may/2022 at 09:16:32.The data point recorded prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 95% 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 16 seconds.No anomalies were recorded leading up to the loss of power.As a result, the reported device thrombus, low flow, and controller loss of power events were confirmed.Additional information received from the site indicated that the patient presented with acute onset severe right sided headache with radiation of pain behind the eye associated with blurry vision, and a head computerized tomography (ct) scan revealed a right subarachnoid hemorrhage.The patient developed sepsis on an intravenous (iv) catheter due to bacteremia found with vegetation on an implantable cardioverter defibrillator (icd) lead.The icd leads and icd generator were successfully removed.Additionally, a thrombus was suspected.An echocardiogram transthoracic (tte) ct scan revealed the aortic valve opening every beat (previously closed).Anticoagulant medication was administered to the patient.Furthermore, a redo sternotomy was performed with extensive adhesiolysis and the patient was treated with iv antibiotics.Furthermore the patient had increasing ldh levels even with treatment, and the pump was then explanted.Of note, a small thrombus in the inflow cannula was reported to have been seen after explant.Per the instructions for use, thrombus, infection, and neurological disfunction are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of infection.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the 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.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.A possible root cause of the controller 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.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 additional event 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 patient received several medications during the prolonged hospitalization that were administered via intravenous (iv), subcutaneous and oral routes.
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Event Description
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It was further reported that the patient was treated with protein and clotting promoter medication via intravenous (iv).
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Manufacturer Narrative
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###a supplemental is being submitted for additional information.Additional information: - b5 desc evt problem: updated to include additional medication administered 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 is being submitted for additional information.Product event summary: ventricular assist device (vad) (b)(6) and the controller ((b)(6)) were returned for evaluation.Various analyses were conducted and reviewed 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 segment of the outflow graft revealed that the device passed visual examination.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front preload measurement, front housing disc curvature, and rear housing disc curvature were found to be deviating from specifications.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 pump.There was no evidence of thrombus within the returned segment of the outflow graft.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection of the returned controller revealed contamination within both power ports, the serial port, and the pump connector; these are additional observations not related to the reported event, likely due to the handling of the device.Log file analysis revealed a sudden decrease in power consumption and estimated flows to parameters below the normal operating range starting on (b)(6) 2022 and sixty (60) low flow alarms logged since (b)(6) 2022.Rev iew of the controller log files also revealed a controller power-up event, with an associated motor start event, logged on (b)(6) 2022 at 09:16:32.The data point recorded prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 95% 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 16 seconds.No anomalies were recorded leading up to the loss of power.As a result, the reported device thrombus, low flow, and controller loss of power events were confirmed.Additional information received from the site indicated that the patient presented with acute onset severe right sided headache with radiation of pain behind the eye associated with blurry vision, and a head computerized tomography (ct) scan revealed a right subarachnoid hemorrhage.The patient developed sepsis on an intravenous (iv) catheter due to bacteremia found with vegetation on an implantable cardioverter defibrillator (icd) lead.The icd leads and icd generator were successfully removed.Additionally, a thrombus was suspected.An echocardiogram transthoracic (tte) ct scan revealed the aortic valve opening every beat (previously closed).Anticoagulant medication was administered to the patient.Furthermore, a redo sternotomy was performed with extensive adhesiolysis and the patient was treated with iv antibiotics.Furthermore, the patient had increasing ldh levels even with treatment, and the pump was then explanted.Of note, a small thrombus in the inflow cannula was reported to have been seen after explant.It was further reported that the patient was treated with protein and clotting promoter medication and received several medications during the prolonged hospitalization which were administered via intravenous, subcutaneous, and oral routes.Per the instructions for use, thrombus, infection, and neurological disfunction are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of infection.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the 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.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 is possible patient, pharmacological, and procedural factors that may have contributed to this event.A possible root cause of the controller 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.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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