MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number EVPROPLUS-26US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Stroke/CVA (1770); Death (1802); Non specific EKG/ECG Changes (1817)
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Event Date 01/21/2020 |
Event Type
Death
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Manufacturer Narrative
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Product analysis: the valve remains implanted therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that following the successful implant of this transcatheter bioprosthetic valve, facial droop was noted.Computed tomography (ct) revealed a left hemispheric stroke with midline shift.The patient was reported to have left sided hemiparesis.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information was received which indicated that the patient died two days after valve implant.The cause of death was stroke.It was unknown if the valve caused or contributed to the death.An autopsy was not performed.Updated a.2 - date of death.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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Additional information was received that a dissection in the left distal iliac was observed.Cutdown and surgical repair were performed to repair the dissection following the valve implant.The cause of the dissection was unknown.The cause of the cerebral infarction was unknown, but contributing factors were prolonged intubation, temporary heart block, and length of the case.An unknown time following the valve implant, the patient passed away.The cause of death was not reported and it is unknown if an autopsy was performed.Section d information references the main component of the system.Other relevant device(s) are: product id d-evprop2329us serial/lot (b)(6) use by date 2020.10.10 udi (b)(4).Patient codes, eval method code.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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