HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1104 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)
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Patient Problems
Paresis (1998); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
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Event Date 07/22/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient presented with neurological symptoms and was admitted for a stroke.Review of logfiles showed some decrease in pulsatility and ventricular assist device (vad) flow, an ongoing vad thrombosis was suspected firsthand.Of note, it was stated that the patient had an outflow graft thrombus.Although, there were no high watts or any signs of increased resistance within the vad, the suspicion was more like a passing thrombus or clinical condition causing the stroke.It was also reported that the patient had therapeutic international normalized ratio (inr), normal lactate dehydrogenase (ldh) level, and normal color of urine.Blood pressure was 93/70 with mean arterial pressure (map) around 75.Post stroke, the patient experienced some paresis of their left arm and leg but no paralysis.During hospitalization, the patient was less mobile and had loss of circadian rhythm.Medical intervention was not performed, and an echocardiogram was scheduled.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.Additional products: brand name: heartware ventricular assist system ¿ outflow graft model #: unk/ catalog #: unk / expiration date: unk / lot#: unk udi #: asku device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun, mfg date: unk, labeled for single use: yes (b)(4).Additional information has been requested regarding the results of echocardiogram results, intervention performed, additional details 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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Manufacturer Narrative
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A supplemental is being submitted for correction.Corrected sections: - h10 addt manufacturer for mdr: img code for the outflow graft (additional product) corrected from "g04019" to "g07001" to better r eflect the device allegation - h10 addt manufacturer for mdr: fdd code for the outflow graft (additional product) corrected from "a1409" to "a24" to better reflect the device allegation additional products: unk ¿ outflow graft h6: img code(s): g07001 h6: fda device code(s): a24 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.Additional information: - b5 desc evt problem: updated to include information that thrombus was not confirmed in the outflow graft 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 outflow graft (ofg) thrombus was not confirmed.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Product event summary: the pump and the associated outflow graft were not returned for evaluation.The reported low flow event was confirmed via log file analysis which revealed a slight decrease in power consumption and estimated flow starting on (b)(6) 2022; however, parameters remained within the normal operating range and no alarms were logged within the analyzed period.Information provided by the site indicated that the patient presented with neurological symptoms and was admitted for a stroke, and device thrombosis was suspected.Post-stroke, the patient experienced paresis of their left arm and leg.During hospitalization, the patient was less mobile and had loss of circadian rhythm.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, device thrombus 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.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, poor vad filling, and/or inappropriate pump rotational sp eed.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 medica tions 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#: unknown - outflow graft h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): 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.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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