Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system ¿ outflow graft: model #: 1125 / catalog #: 1125 / expiration date: 28-feb-2023 / serial or lot#: (b)(4); udi #: (b)(4); device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 01-feb-2018.Labeled for single use: no.(b)(4).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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It was reported that the patient was admitted to the hospital with symptoms from an ischemic stroke.The ventricular assist device (vad) flows were initially low, and that was followed by a period of abnormally high power.The patient's lactate dehydrogenase (ldh) was elevated throughout.A computerized tomography angiography (cta) scan revealed a possible thrombus or biological debris in the distal portion of the outflow graft.The patient was not a candidate for thrombolytics due to their neurological status.After continued neurological decline, the patient was transferred to comfort care.The patient subsequently expired, and the official cause of death was reported as stroke.
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A supplemental report is being submitted for device evaluation and a correction.Outflow graft (17188210-0894) h5 label for single use was corrected from no to yes.Product event summary:(b)(6) and the associated outflow graft (lot number: 17188210-0894) were not returned for evaluation.Review of the available controller log files revealed an increase in power consumption and estimated flows leading to parameters above the normal operating range starting on (b)(6) 2022.Review of the alarm log file revealed one hundred and twenty-five (125) low flow alarms logged since (b)(6) 2022.As a result, the reported high power and low power events were confirmed.Information provided by the site indicated that in addition to the low and high power events, the patient was admitted to the hospital with symptoms from an ischemic stroke.The patient's lactate dehydrogenase (ldh) was elevated throughout.A computerized tomography angiography (cta) scan revealed a possible thrombus or biological debris in the distal portion of the outflow graft.The patient was not a candidate for thrombolytics due to their neurological status.After continued neurological decline, the patient was transferred to comfort care.The patient subsequently expired, and the official cause of death was reported as stroke.Based on the available information, the device may have caused or contributed to the reported event.Based on the available information and historical review of similar events, the most likely root cause of the reported high power event can be attributed to external factors such as thrombus formation/ingestion.Based on the risk documentation, multiple factors may have contributed to the observed low flow event 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, thrombus, and death 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 neurological dysfunction.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 anticoagu lant 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: lot#: 17188210-0894.H5: yes 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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