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MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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| Model Number EVOLUTR-23-C |
| Device Problems
Calcified (1077); Perivalvular Leak (1457); Incomplete Coaptation (2507)
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| Patient Problems
Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Dyspnea (1816); Insufficiency, Valvular (1926); No Code Available (3191); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 09/22/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product has been returned for analysis.A supplemental report will be filed upon completion of the analysis.Conclusion: not yet available, evaluation of the product is in progress.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 approximately five years following the implant of this transcatheter bioprosthetic valve, an ele ctrocardiogram (ecg) showed a peak aortic valve (pav) velocity of 4.1 and an aortic mean gradient of 36.7 millimeter of mercury (mmhg).No treatment was reported.Increasing dyspnea and activity intolerance then presented.Approximately five years, four months and four days following the implant of the valve, moderate to severe central aortic regurgitation and severe paravalvular leak (pvl) were identified.As reported, congestive heart failure occurred as a result of the valve failure.Four days later the valve was explanted and replaced with a non-medtronic valve.During explant, the valve was found to be extensively incorporated into the aortic wall with evidence for early calcification of the leaflets.In-stent stenosis, incomplete closure of the leaflets, and continued aortic insufficiency were also noted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Product analysis: upon receipt at medtronic¿s quality laboratory, valve was received in an explant kit, submerged in clear 0.2% glutaraldehyde solution.Three native valve leaflets and one host remnant were returned alongside the transcatheter valve.The native valve leaflets exhibited imprints of the transcatheter valve frame.Thick circumferential off-white pannus remained attached to the outflow frame.The outflow frame appeared distorted and oval-shaped.Extensive extrinsic calcification nodules were observed on the outflow of all leaflets and restricted leaflet mobility.From the inflow, all leaflets were smooth except where host tissue and / or calcification extended.There was a tear on one leaflet appearing to be a result of the adjacent heavy calcification.All leaflets were in the closed position with gaps between all free margins.Off-white pannus appeared to fully encapsulate two commissures with extensive calcification nodules observed distal to the commissures.The second commissure was fully encapsulated with off-white pannus.From the inflow aspect, thick, glistening off-white pannus adhered to the inflow crown tips extending to the luminal surface of the skirt up to the inflow margin of attachments of all leaflets.Multi-focal tan pannus adhered to the abluminal surface of the skirt extending to the margin of attachment of all leaflets.Thick off-white pannus lined the outflow margin of attachments of all leaflets.From the outflow aspect, thick circumferential off-white pannus remained attached to the outflow frame.The three native valve leaflets were thick with calcification nodules.Unknown amount of pannus may have been removed during explant.Radiography revealed calcification on all leaflets.Conclusion: the investigation is in progress.Eval code method: updated to b01 eval results code: updated.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 which indicated that initially following the implant of this transcatheter valve, the discharge echocardiogram had identified a gradient of 39.6 millimeters of mercury (mmhg) and mild paravalvular leak (pvl).No additional adverse patient effects were reported.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.
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Manufacturer Narrative
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Conclusion: the device history record (dhr) for this valve was reviewed and showed that this device met all manufacturing specifications for final product released for distribution.No issues were identified that would have impacted this event.The images submitted were reviewed and confirmed calcium had built up over time in this previously implanted medtronic valve.The evidence provided confirmed the valve was removed from the body and showed significant calcium that formed on the interior of the valve frame attached to the leaflets.There was no imaging to confirm the echo measurements as stated in this event report.High gradients increase over time are typically related to patient factors such as, but not limited to, thrombus formation, calcification, patient pressures, and/or anatomical left ventricular outflow tract (lvot) obstruction, etc.A conclusive root cause could not be determined but the extensive calcification could have been a contributing cause.Aortic regurgitation and paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.In this case, a conclusive cause could not be determined from the information available, but the extensive calcification and incomplete leaflet closure could have been a contributing cause.Heart failure is listed in the device instructions for use (ifu) under potential adverse events, and can be related to several factors (procedure, patient comorbidities, etc.).A relationship of the reported congestive heart failure to the device or procedure could not be determined with the information available, though it is likely related to patient condition as the patient was reported to have a metabolic disorder that causes connective tissue issues.Calcification is a bioprosthetic valve failure that is patient influenced.As calcium deposits form on the valve, they can potentially cause narrowing at the opening of the valve.The presence of calcification and its rate of formation is dependent on patient co ndition (e.G., blood chemistry).Calcification was confirmed from radiography of the valve during the product analysis.With the information provided, the root cause of the calcification could not be conclusively determined.In the device ifu, calcification is also listed as a potential adverse event associated with the implantation of the valve.Stenosis is a known potential adverse effect per the evolutr ifu.Stenosis of bioprosthetic valves can be a manifestation of structural valve dysfunction (e.G.Calcification), thrombosis, and/or non structural dysfunction (e.G.Pannus, obstruction, etc.).Several factors can contribute to the onset and propagation of either failure mechanism such as patient medical history (age, disease stage, comorbidities, etc.), pharmacological factors, and/or intrinsic properties of the valve itself.With the information available, a conclusive root cause could not be determined but the extensive calcification and pannus observed during the product analysis were likely contributing causes.The reported inability of the valve leaflets to coapt (which was confirmed during the product analysis as gaps between all free margins) could possibly be related as a common structural valve degeneration (svd) mechanism of failure (or failure mode) such as cuspal deformation or tearing.A tear was observed on leaflet 1 during the product analysis and appeared to be a result of the adjacent heavy calcification.However, a conclusive root cause for the incomplete coaptation could not be made.In conclusion, this event does not indicate device misuse or malfunction and there was no information to suggest a device quality deficiency that may have caused or contributed to this event.Updated data h6: method and conclusion codes 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 analysis/conclusion: the valve was sent to the cvpath institute for additional analysis.The additional analysis reported fragments of tan-white fibrous tissue are adherent to the outer and inner frame surfaces, completely covering the skirt on the inflow surface where it forms a circumferential ridge of fibrous tissue (pannus) extending to the base of the valve leaflets.All valve leaflets show nodular calcification predominantly on the aortic surface, are moderately non-pliable due to basal pannus on the aortic surface and show a central gap.There are no leaflet tears, thrombi, or vegetations.Micro computed tomography (ct) and radiographic imaging showed an intact valve without any fracture.There is evidence of marked calcification involving all three bioprosthetic leaflets.Histologic sections of all three valve leaflets showed extensive calcification that was intrinsic and involved the free edge, two of three commissures and base of the valve as well.Mild inflammation was occasionally, focally present but was minimal and was only seen on the aortic surface.Only one area near the base in leaflet 3 showed mild presence of organizing thrombus which was of no significance.Overall, valve degeneration was observed in all three leaflets.Calcification was confirmed from radiography of the valve during the product analysis as well as the cvpath institute analysis.With the information provided, the root cause of the calcification could not be conclusively determined but was likely related to patient condition, which included alkaptornuria.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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