HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Numbness (2415); Convulsion/Seizure (4406); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Paresthesia (4421)
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Event Date 06/01/2022 |
Event Type
Death
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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.Concomitant medical products: dtma1qq crt-d implanted: (b)(6) 2020; 429888 lead implanted: (b)(6) 2020.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 presented to the emergency department with a neurological dysfunction.The patient was experiencing stroke like symptoms including numbness and tingling.A computerized tomography (ct) brain/head scan was performed.The patient was intubated in the intensive care unit (icu) with continuous electroencephalogram monitoring.It was noted that the patient had an acute ischemic stroke with conversion to hemorrhagic stroke and was having multiple seizures.The ventricular assist device (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 device evaluation and investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Review of the controller log files did not reveal any anomalies within the analyzed period.Information received indicated that the patient presented to the emergency department with a neurological dysfunction.The patient was experiencing stroke-like symptoms including numbness and tingling.A computerized tomography (ct) brain/head scan was performed.The patient was intubated in the intensive care unit (icu) with continuous electroencephalogram monitoring.It was noted that the patient had an acute ischemic stroke with conversion to hemorrhagic stroke and was having multiple seizures.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.There was no evidence 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.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 information.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 subsequently expired.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation and a revision to the product event summary.Revised product event summary: (b)(6) was not returned for evaluation.This complaint is associated with a clinical adverse event.Review of the controller log files revealed power consumption below the normal operating range within the analyzed period.Information received from the site indicated that the patient presented to the emergency department with neurological dysfunction.The patient was experiencing stroke-like symptoms including numbness and tingling.A computerized tomography (ct) brain/head scan was performed.The patient was intubated in the intensive care unit (icu) with continuous electroencephalogram monitoring.It was noted that the patient had an acute ischemic stroke with conversion to hemorrhagic stroke and was having multiple seizures.It was further reported that the patient subsequently expired.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 observed below normal power event may be attributed to multiple f actors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Per the instructions for use, neurological dysfunction and death are a known potential complications associated with the implantation of a vad.There was no evidence the patient had a history of neurological dysfunction 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.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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