MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-29-US |
Device Problems
Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583); Activation Failure (3270)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 01/04/2023 |
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.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 three years, one month, and six days following the implant of this transcatheter bioprosthetic valve into an existing surgical valve, the patient presented with moderate-severe central aortic insufficiency (ai) and a gradient of 50mmhg.The valve frame appeared constrained.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 24mm non-medtronic balloon.Following the bav, a second transcatheter valve was implanted valve-in-valve successfully.No ai or paravalvular leak was observed; however, a gradient of 20mmhg was noted.Subsequently, a post-implant bav was performed using a 23mm non-medtronic balloon.Following the bav, the same issue occurred.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the initial implant depth of the 29 mm valve in the surgical valve was shallow around 1-2 millimeter (mm) on the non-coronary cusp (ncc) and left coronary cusp (lcc).The 26 mm valve was implanted approximately 2-3 mm below the 29 mm valve.It was reported that the 29 mm valve was most likely constrained because the true id of the surgical valve was 22mm and the stent id was 24 mm.The valve is sized off the stent id.The patient anatomy was large and therefore a 29 mm was implanted and the leaflets may have been pin wheeling due to them being constrained.The elevated gradient was most likely patient-prosthesis mismatch (ppm) related.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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