MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTFX-23 |
Device Problem
Perivalvular Leak (1457)
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Patient Problems
Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 01/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, the patient had a failed 21 millimeter (mm) medtronic surgical valve.The valve was deployed and during the echocardiogram, mild to moderate paravalvular leak (pvl) was noted.A post-balloon aortic valvuloplasty (bav) was performed.Upon retrieval, the balloon became entangled on the top of the valve frame.Attempts of pushing and pulling was performed to free the balloon until it became loose and the balloon was retrieved.A transesophageal echocardiogram (tee) revealed that the pvl was worse and central regurgitation was noted.It was determined that the valve dislodged aortic upon the entanglement of the balloon and in the process of de-tangling it.A new valve was implanted successfully through the first valve.Mild residual pvl was reported post implant of the second valve.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Updated data: b5 - event description 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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Event Description
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Additional information was received that following the valve implant, the transesophageal echocardiogram (tee) revealed mild to moderate paravalvular leak (pvl) and mild central regurgitation.No pre-implant balloon aortic valvuloplasty (bav) was performed.The deployment starting point was at the bottom of the pigtail.Prior to the valve dislodgement, the approximate implant depth was 3 millimeter (mm) on the non-coronary cusp (ncc) and 5 mm on the left coronary cusp (lcc).After the valve dislodged, the valve was just above the annulus revealing severe pvl.No additional adverse patient effects were reported.
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