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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It was reported that the patient was hospitalized for suspicion of thrombus due to ventricular assist device (vad) high power and flows with high watt alarms.The patient had hematuria, elevated lactate dehydrogenase (ldh) of 1707, creatinine increased to 2.0 from 1.5, b type natriuretic peptide (bnp) elevated at 501 (h), and haptoglobin serum was less than 30 (l).The patient was started on a heparin drip.It was noted that the patient¿s international normalized ratio (inr) was therapeutic, and the patient was too frail and not a candidate for a vad exchange.The patient was treated with tissue plasminogen activator (tpa) and remained hospitalized in acute renal failure.The vad remains in use.No further patient complications have been reported as a result of this event.
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A supplemental report is being submitted for device evaluation.Product event summary: (b)(6) was not returned for evaluation.The reported high power event was confirmed through log file analysis which revealed an increase several in power consumption and estimated flows starting on 26/jun/2022, followed by a spike in power consumption and estimated flows on 28/jun/2022, all leading to parameters above normal operating range.A return to baseline parameters was logged on 29/jun/2022.Twenty four (24) high watt alarms were logged since 27/jun/2022.Information received from the site indicated that the patient was hospitalized for suspicion of thrombus due to ventricular assist device (vad) high power and flows with high watt alarms.The patient had hematuria, elevated lactate dehydrogenase (ldh) of 1707, creatinine increased to 2.0 from 1.5, b type natriuretic peptide (bnp) elevated at 501 (h), and haptoglobin serum was less than 30 (l).The patient was started on a heparin drip.It was noted that the patient¿s international normalized ratio (inr) was therapeutic, and the patient was too frail and not a candidate for a vad exchange.The patient was treated with tissue plasminogen activator (tpa) which corresponds with the return to baseline parameters observed in the log files.The patient remained hospitalized in acute renal failure.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 high power events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Per the instructions for use, device thrombus, hemolysis, and renal 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.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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