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Additional information has been requested regarding the patient's gender and outflow graft lot number, 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.Additional products: heartware ventricular assist system ¿ outflow graft, model #: 1125 / catalog #: 1125x / expiration date: unk / lot#: unk, udi #: (b)(4).Device available for evaluation : no.Device manufacture date: unk.Labeled for single use : no.(b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
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It was reported that on post-operative day (pod) 9 the patient was taken back to the operating room (or) for increased chest tube drainage.Two sources of bleeding were found, one at the outflow graft (ofg) to aortic anastomosis, and the other from a suture in the ofg were a pledget had been placed to repair the needle hole used for de-airing.The patient¿s chest was left open and then closed on pod 10.On pod 11 the patient was taken back to the or for bleeding in their lower chest, a source was located and corrected.The ventricular assist devices exhibited low flows and suction due to the bleeding.The patient received blood transfusions.Initially the patient was started on heparin and aspirin on pod 1.Anticoagulation was held beginning on pod 9 due to bleeding.The plan was to resume anticoagulation, but on pod 11 the power on the vad increased and was high and heparin was started.The patient¿s lactate dehydrogenase (ldh) was elevated and the patient had dark urine.A pump thrombus was suspected.A head computerized tomography (ct) showed hyper attenuation of right frontal lobe, and the patient was diagnosed with an embolic cerebrovascular accident (cva).The patient had been sedated so the exact date of the event is unknown.Sedation was stopped, the patient awoke, and answered all questions appropriately.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 as additional information was received.Updated sections: a3 sex: from female to male additional products: outflow graft lot#: from unk to 17531279-1521; udi #: from asku to (b)(4) correction h6:fda device code(s): from blank to a141204 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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A supplemental report is being submitted for analysis and investigation completion.Product event summary: the pump (b)(6) and associated outflow graft (lot.No.17531279-1521) were not returned for evaluation.The reported outflow graft leak could not be confirmed due to insufficient evidence.Review of the primary controller (con414463) log files revealed several increases and decreases in power consumption within the analyzed period of (b)(6) 2021 through (b)(6) 2021.39 high watt alarms were logged since 05/may/2021, 26 low flow alarms were logged since (b)(6) 2021 and 5 suction alarms were logged since (b)(6) 2021.No vad stopped alarms were logged within the analyzed period.As a result, the reported low flow alarms, suction alarms, and high power events were confirmed; however, the reported vad stopped event could not be confirmed.Information received from the site indicated that the patient was admitted due to increased chest tube drainage.Sources of bleeding were identified which includes the lower chest, outflow graft anastomosis site, and a suture in the outflow graft where a pledget had been placed to repair the needle hole used for de-airing.The patient also received blood transfusions and was started on heparin and aspirin.Anticoagulation was held at the time of bleeding; however when the patient was set to resume, the power consumption on the pump increased and heparin was started.The patient then experienced elevated lactate dehydrogenase (ldh) levels, dark urine, and a pump thrombus was suspected.A head computerized tomography (ct) showed hyper attenuation of right frontal lobe, and the patient was diagnosed with an embolic cerebrovascular accident (cva).Once sedation was stopped, the patient awoke and answered all questions appropriately.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue 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 high power event can be attributed to external factors such as thrombus formation/ingestion.Based on the risk documentation, possible causes of the low flow event/suction 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, inappropriate pump rotational speed.Based on the available information, a possible root cause of the reported "outflow graft leak at aortic anastomosis and de-airing needle hole" event can be attributed, but not limited to operator's technique during implant.Per the instructions for use, bleeding, 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.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.Additional products: d4: lot#: 17531279-1521 h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d12, d14 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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