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Model Number VNMC3731C207TU |
Device Problems
Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Coma (2417); Heart Failure/Congestive Heart Failure (4446)
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Event Date 05/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Valiant navion stent grafts were implanted in the patient for an endovascular treatment.After receiving a letter from the hospital >1 year post procedure regarding the navion recall the patient became concerned and a representative for the patient contacted technical services to report since their procedure they have had no follow up.It was reported after the procedure the patient was in icu for 10 days in a medically induced coma.The patient still hasn't recovered from the procedure and has been experiencing shortness of breath and extreme fatigue with high blood pressure.No additional clinical were reported and the patient will be monitored.
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Manufacturer Narrative
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Additional information received:; it was reported as per the physician the patients symptoms were due to heart failure secondary to pre existing disease.It was reported a possible type ia endoleak was observed at the most recent ct approximately 1 year post the index procedure.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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Product analysis the reported proximal endoleak was confirmed on the films provided; however, the exact cause of the event could not be determined.The anatomy at implant is unknown and the later noted post-implant films were not provided for comparison.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.Analysis of the returned films did not reveal any obvious out of specification stent graft integrity issues.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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Search Alerts/Recalls
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