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MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number EVOLUTR-34-C |
| Device Problems
Calcified (1077); Gradient Increase (1270); Activation Failure (3270); Material Split, Cut or Torn (4008)
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| Patient Problems
Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
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| Event Date 08/18/2022 |
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Event Type
Injury
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Manufacturer Narrative
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The product has been returned for analysis.A supplemental report will be filed upon completion of the analysis.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 approximately 5 years and 6 months following the implant of this 34 millimeter (mm) transcatheter bioprosthetic aortic valve, an echocardiogram identified severe aortic regurgitation (ar) with an eccentrically directed jet.The mean gradient measured 21 millimeters of mercury (mmhg) and leaflet perforation was suspected.One day later a transesophageal echocardiogram (tee) showed severe aortic insufficiency through the perforated leaflet.The ar was estimated to be greater than 100 milliliters per beat.Secondary to the perforated leaflet, acute on chronic diastolic heart failure was observed.B-type natriuretic peptide (bnp) was measured in the 3500¿s picograms per milliliter (pg/ml) and increased pulmonary arterial (pa) pressures were noted.Medication was administered due to shock and heart failure.Seven days after presenting, a sternotomy was performed to explant the transcatheter bioprosthetic aortic valve.A non-medtronic 25 mm surgical aortic valve was implanted and resolved the event without sequelae.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received which indicated that prior to the aortic bioprosthetic transcatheter valve implant the mean gradient was 31 millimeters of mercury (mmhg).Following implant at discharge the mean gradient was 7.9mmhg.The valve was successfully implanted on the first attempt.A post-balloon aortic valvuloplasty (bav) was performed with a 26 millimeter (mm) balloon.The reason was not provided.Additionally, a left atrial appendage ligation (laal) was preformed with the valve revision.No additional adverse patient effects were reported.Street address 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 at the 5 year follow-up, which was approximately 1 month prior to the previously reported heart catheterizations, a transthoracic echocardiogram (tte) identified an aortic mean gradient of 7.5 mmhg.No additional adverse patient effects were reported.
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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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Manufacturer Narrative
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B5 - additional information: additional information was received which indicated that no pre-implant bav was performed when the valve was implanted.Approximately 5 years and 2 months following the implant of the valve, the patient reported persistent shortness of breath.Two heart catheterizations were subsequently performed and attributed as the cause of the perforated leaflet.The two heart catheterizations were reported as not a result of the valve.No additional adverse patient effects were reported.H6 - patient codes: added e0717.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 at the time of the initial implant of the transcatheter aortic valve, the post balloon aortic valvuloplasty (bav) was performed with a 26 millimeter (mm) non-medtronic balloon due to residual under-expansion and an elevated gradient.One inflation was performed.The initial implant depth was 3mm on the non-coronary cusp (ncc) and 1mm on the left coronary cusp (lcc).At the time of the transcatheter explant, dense calcifications of the transcatheter valve leaflets were noted.Per the valve revision physician, the perforation was caused by a heart catheterization that had been performed.No additional adverse patient effects were reported.Updated data: h6 additional device 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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Updated data: b5.Sixth paragraph additional codes.Imf code added.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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Event Description
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Medtronic received information that approximately 5 years and 6 months following the implant of this 34 millimeter (mm) transcatheter bioprosthetic aortic valve, an echocardiogram identified severe aortic regurgitation (ar) with an eccentrically directed jet.The mean gradient measured 21 millimeters of mercury (mmhg) and leaflet perforation was suspected.One day later a transesophageal echocardiogram (tee) showed severe aortic insufficiency through the perforated leaflet.The ar was estimated to be greater than 100 milliliters per beat.Secondary to the perforated leaflet, acute on chronic diastolic heart failure was observed.B-type natriuretic peptide (bnp) was measured in the 3500¿s picograms per milliliter (pg/ml) and increased pulmonary arterial (pa) pressures were noted.Medication was administered due to shock and heart failure.Seven days after presenting, a sternotomy was performed to explant the transcatheter bioprosthetic aortic valve.A non-medtronic 25 mm surgical aortic valve was implanted and resolved the event without sequelae.No additional adverse patient effects were reported.Additional information was received which indicated that prior to the aortic bioprosthetic transcatheter valve implant the mean gradient was 31 millimeters of mercury (mmhg).Following implant at discharge the mean gradient was 7.9mmhg.The valve was successfully implanted on the first attempt.A post-balloon aortic valvuloplasty (bav) was performed with a 26 millimeter (mm) balloon.The reason was not provided.Additionally, a left atrial appendage ligation (laal) was performed with the valve revision.No additional adverse patient effects were reported.Additional information was received which indicated that at the time of the initial implant of the transcatheter aortic valve, the post balloon aortic valvuloplasty (bav) was performed with a 26 millimeter (mm) non-medtronic balloon due to residual under-expansion and an elevated gradient.One inflation was performed.The initial implant depth was 3mm on the non-coronary cusp (ncc) and 1mm on the left coronary cusp (lcc).At the time of the transcatheter explant, dense calcifications of the transcatheter valve leaflets were noted.Per the valve revision physician, the perforation was caused by a heart catheterization that had been performed.No additional adverse patient effects were reported.Additional information was received which indicated that no pre-implant bav was performed when the valve was implanted.Approximately 5 years and 2 months following the implant of the valve, the patient reported persistent shortness of breath.Two heart catheterizations were subsequently performed and attributed as the cause of the perforated leaflet.The two heart catheterizations were reported as not a result of the valve.No additional adverse patient effects were reported.Additional information was received that at the 5 year follow-up, which was approximately 1 month prior to the previously reported heart catheterizations, a transthoracic echocardiogram (tte) identified an aortic mean gradient of 7.5 mmhg.No additional adverse patient effects were reported.Additional information was received that the first cardiac catheterization was classified as diagnostic.The second cardiac catheterization was diagnostic with treatment of stent placement.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Analysis: the device was received inside a hospital specimen jar in a cloudy red solution.Visual evaluation of the returned device identified a tear in leaflet 1 at the stitchline along the margin of attachment up to the inferior coaptive junction.A remnant of leaflet was noted at the superior coaptive junction to the inferior coaptive junction.A small gouge was noted on the outflow belly.Extrinsic calcification was observed on the shoulder near the margin of attachment.Leaflet 2 had glistening off-white pannus at the base and belly.Extrinsic calcification was noted on the outflow and inflow sides.An approximate 3-4 millimeter (mm) tear was noted at the inferior coaptive junction.Leaflet 3 contained a tear with frayed edges on the superior coaptive junction going to node 5 with remnant leaflet tissue on the commissure.Commissure evaluation noted a thin layer of pannus encapsulated all commissures.Regarding coaptation, leaflet 1 appeared to be in a closed position with some prolapse due to the leaflet tear.Leaflet 2 appeared partially open.Leaflet 3 was in a closed position.Glistening, off-white pannus adhered to the outflow of the frame.A thick layer of glistening off-white pannus was observed on the inflow crown.Extrinsic calcification was noted along the inflow crown and outer valve surface.Pannus extended into the inner lumen, up to node 3.Radiography revealed calcification at the valve inflow crown and leaflets.Conclusion: not yet available, evaluation of the product is in progress.Updated data: h3, h6 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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Manufacturer Narrative
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Analysis: the device history record (dhr) of the valve with serial number (b)(6) confirmed that all process requirements and device specifications were met as outlined in applicable procedures and prior to release for distribution.All materials used were as per the requirements.There was not found rework records of non-conformances nor deviations references for the valve.There are no correlations nor manufacturing issues identified related to this event.Frame record review was performed based on manufacturing records of the valve met all acceptance criteria, vendor confirmation and evidence that the frame was manufactured with no parts rejected, history acceptance results from incoming inspection and controls placed along the transcatheter aortic valve (tav) manufacturing process, it was concluded that involved frame lot complied all process requirements and component specifications as outlined in applicable procedures.Transthoracic echo (tte) images provided from approximately four months prior to valve explant.Tte images provided appear to be before leaflet perforation occurred.The patient had an the transcatheter aortic valve in place and the device implant location was good.Mean aortic valve (av) gradient was 3.4 millimeters of mercury (mmhg), but line of interrogation was not quite parallel to flow, thus, the gradient could be underestimated.Prosthetic leaflets appeared thickened with possible pannus/thrombus.Possible mild paravalvular regurgitation (pvl) was noted.More views were required to verify pvl versus a central leak.The scan plane on the short axis av view provided was just below the valve.Imaging plane should have been at native annular plane level to assist with pvl quantification and to help verify pvl leak versus central leak.Ejection fraction was 55-60%.Research and development team completed an investigation of the valve.The device was received inside a hospital specimen jar in a cloudy red solution.Visual evaluation of the returned device identified a tear in leaflet 1 at the stitchline along the margin of attachment up to the inferior coaptive junction.A remnant of leaflet was noted at the superior coaptive junction to the inferior coaptive junction.A small gouge was noted on the outflow belly.Extrinsic calcification was observed on the shoulder near the margin of attachment.Leaflet 2 had glistening off-white pannus at the base and belly.Extrinsic calcification was noted on the outflow and inflow sides.An approximate 3-4 millimeter (mm) tear was noted at the inferior coaptive junction.Leaflet 3 contained a tear with frayed edges on the superior coaptive junction going to node 5 with remnant leaflet tissue on the commissure.Commissure evaluation noted a thin layer of pannus encapsulated all commissures.Regarding coaptation, leaflet 1 appeared to be in a closed position with some prolapse due to the leaflet tear.Leaflet 2 appeared partially open.Leaflet 3 was in a closed position.Glistening, off-white pannus adhered to the outflow of the frame.A thick layer of glistening off-white pannus was observed on the inflow crown.Extrinsic calcification was noted along the inflow crown and outer valve surface.Pannus extended into the inner lumen, up to node 3.Radiography revealed calcification at the valve inflow crown and leaflets.Conclusion: per the event description, a perforation on one of the leaflets had been suspected from the heart catheterization that had been performed.No perforation was observed on any of the three leaflets.Leaflet 1 appeared to have a visible gouge- an appearance of a dent, which could have been from the referenced heart catheterization interacting with the leaflet.Tears near stitch line were observed on all 3 leaflets.All leaflets have a tear at high stress areas.It was likely that the tearing of these leaflets was a combination of fatigue and calcification inducing a tear.It was difficult to conclude weather there was an initiating wear that would have contributes to the fatigue failure of the leaflets due to post-implant balloon aortic valvuloplasty (bav) because the details of the balloon used were incomplete.The impact of catheterization at 5 years and 2 months was unclear.Observations on the valve cannot easily be linked to adverse catheter interaction which could initiate wear that would have contributed to the fatigue failure.High gradients can be related to valve related factors (degeneration, thrombus, calcification) or non-valve related factors (lvot obstruction, patient pressures, lv dysfunction).With the information available, no root cause can be assigned, however valve calcification, and pannus and the cuspal tear are likely contributing factors.Regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.A conclusive cause could not be determined, however valve calcification, and pannus and the cuspal tear are likely contributing factors.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 cond ition (e.G., blood chemistry).A conclusive root cause could not be determined.Heart failure is listed in the device ifu under potential adverse events, and can be related to several factors (procedure, patient comorbidities).A conclusive relationship between the reported congestive heart failure and the device or procedure could not be de termined with the information available, however valve calcification, and pannus and the cuspal tear are likely contributing factors.Hypertension is a known potential adverse effect per the device ifu, with a variety of factors that can influence its onset.A conclusive root cause could not be determined, however valve calcification, and pannus and the cuspal tear are likely contributing factors.Per the device instructions for use (ifu), in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilation of the bioprosthesis may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.¿ the balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Refer to the specific balloon catheter manufacturer's labeling for proper instruction on the use of balloon catheter devices.A post implant balloon aortic valvuloplasty (bav) was performed.A conclusive root cause of the cuspal tear and the lack of frame expansion cannot be determined at this time.To better investigate issues of leaflet damage as a result of cuspal tears, corrective action/preventive action (capa) had been opened, capa 463201, with corrective actions taken to update the ifu with table 3.This capa was closed, however medtronic continues to monitor the trends.Updated data: h6 method, result 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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