MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number MCS-P3-31-AOA |
Device Problems
Calcified (1077); Perivalvular Leak (1457)
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Patient Problem
Valvular Insufficiency/ Regurgitation (4449)
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Event Date 02/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted and no procedural images were submitted for review; therefore, no product analysis can be performed.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 following the implant of this transcatheter aortic bioprosthetic valve (tav), trace-mild paravalvular leak (pvl) with a peak gradient of 12 mm hg and a mean gradient of 6 mm hg was noted.No treatment was reported.Over five years following valve implant, the patient was scheduled for a post-implant balloon aortic valvuloplasty (bav) with consideration to also perform a tav-in-tav due to a reduced left ventricle ejection fraction of 35-40% and the pvl that increased to moderate-severe at the left coronary cusp (lcc).Of note, the lcc had presence of dense calcification.In addition, the peak gradient increased to 36 mm hg and a mean gradient of 18 mm hg.The bav was performed using a 26 mm balloon; however, it was confirmed to be unsuccessful in significantly reducing the pvl.Subsequently, a tav-in-tav was performed with a 26 mm non-medtronic (sapien 3 ultra) valve.The pvl reduced to trace-mild.No adverse patient effects were reported; no further information will be provided due to patient confidentiality.
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Manufacturer Narrative
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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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