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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-29-C |
| Device Problems
Calcified (1077); Gradient Increase (1270); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Central Regurgitation (4068)
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| Patient Problems
Dyspnea (1816); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Pulmonary Edema (2020); Cusp Tear (2656); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)
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| Event Date 09/17/2023 |
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Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted, 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 has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted. 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 6 years 2 months following the implant of this transcatheter bioprosthetic valve, the patient was evaluated for a transcatheter valve replacement.A transesophageal echocardiogram (tee) and computed tomography (ct) scan were performed that revealed left coronary cusp (lcc) calcification and a distal leaflet tear.The other leaflets appeared thin with normal mobility.It was noted that the changes appeared degenerative, but thrombus or vegetation could not be excluded.Additionally, it was reported that moderate central aortic regurgitation was observed.No paravalvular leak (pvl) or stenosis were reported.It was noted that mild mitral regurgitation was observed.The patient was subsequently scheduled for a valve-in-valve procedure.No additional adverse patient effects were reported.
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Event Description
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Medtronic received information that 6 years 2 months following the implant of this transcatheter bioprosthetic valve, the patient was evaluated for a transcatheter valve replacement.A transesophageal echocardiogram (tee) and computed tomography (ct) scan were performed that revealed left coronary cusp (lcc) calcification and a distal leaflet tear.The other leaflets appeared thin with normal mobility.It was noted that the changes appeared degenerative, but thrombus or vegetation could not be excluded.Additionally, it was reported that moderate central aortic regurgitation (ar) was observed.No paravalvular leak (pvl) or stenosis were reported.It was noted that mild mitral regurgitation was observed.The patient was subsequently scheduled for a valve-in-valve procedure.No additional adverse patient effects were reported.Additional information was reported that 6 years, 1 month, and 20 days following the implant of this transcatheter bioprosthetic valve, the patient was admitted to the hospital.Shortness of breath related to acute on chronic congestive heart failure (chf) was experienced.Pulse oximeter was 91% on room air and was placed on 2 liters of oxygen via nasal cannula.Oxygen level increased to 98%.B-type natriuretic peptide (bnp) results 858.0 picogram per milliliter (pg/ml).Furosemide was administered.Testing revealed an issue with the valve.Computed tomography (ct) images showed moderate bilateral pleural effusion in the setting of aortic valve disease.Transthoracic echocardiogram (tte) showed a peak aortic gradient of 125 millimeters of mercury (mmhg) and a mean gradient of 7mmhg.Echocardiogram performed approximately 8 months prior showed a well seated valve with a peak aortic gradient of 13.97mmhg and a mean gradient of 75mmhg.Chest x-rays were performed three days after presenting and revealed trace pleural effusion and development of mild pulmonary edema.A repeat tte was performed and showed an ejection fraction (ef) of 65% with a possible prolapse of the aortic valve.Tee showed a well seated aortic valve, with a peak aortic gradient of 17.64mmhg and a mean gradient of 9.68mmhg, with moderate to severe aortic regurgitation.Peak velocity was 2.2 meters per second (m/sec), a mean gradient 9mmhg and an effective orifice area (eoa) of 2.0 cm2.Prior to the valve-in-valve procedure, imaging showed dark regions near the valve¿s non-coronary cusp (ncc) that were possibly pannus or thrombus.Calcification near the valve frame in the right coronary cusp (rcc), lcc and ncc at approximately 4.7 millimeter (mm) above the inflow.Calcification was near the proximal right coronary artery (rca).Protruding calcification under the lcc extended into the left ventricular outflow tract (lvot) and was "under the" ncc.Calcium under the rcc extended approximately 1.8mm below the inflow.Additional information was received that two days prior to the valve implant, the mean mitral valve gradient was 4 mm hg due to moderate mitral "annular" calcification.The cause of the mitral regurgitation was not commented on; instead, it was documented the presence of diffuse mitral leaflet sclerosis.Focal calcifications of mitral valve shordae.No significant stenosis and trace mitral regurgitation.Endocarditis was not confirmed; there were no predisposing factors, no positive medical history or endocarditis.The final implant depth was -1mm on the ncc and 3mm on the lcc.A post-implant balloon aortic valvuloplasty (bav) was performed using a 24mm balloon.The valve mean gradient at discharge was12mm hg, with zero pvl and zero mitral regurgitation.Approximately five years, five months following valve implant, the ejection fraction from the aortic valve was 70% with a mean gradient of 7 mm hg.Approximately six years, two months following valve implant, a possible leaflet prolapse of the aortic valve was noted.The mean gradient was 10 mm hg with moderate-severe ar.In addition, severe mitral annular calcification was appreciated with thickening/fibrosis of the mitral valve leaflets.The mitral valve mean gradient was 5 mm hg and 65 beats/minute with trace mitral regurgitation.A tee showed a well-seated medtronic valve with lcc focally calcified with a distal leaflet tear.The leaflet in the "anatomic" ncc has "strands" 0.8cmx0.1cm which appear degenerative, but cannot exclude thrombus or vegetation.Moderate central aortic regurgitation (vena contracta 0.4 cm, vc area 0.27 cm2) with no pvl.No prosthetic aortic stenosis (peak velocity 2.2 m/s, mean gradient 9 mm hg, and eoa 2.0, di 0.72).Mean mitral gradient 9 mm hg at 80 beats/minute.The patient was prescribed a daily aspirin following valve implant.Five days later, cardiac catheterization did not reveal any obstructive coronary artery disease.It was noted the initial hospitalization was for congestive heart failure.Approximately six years, two and a half months following the transcatheter bioprosthetic valve implant, the aortic valve was replaced with a surgical aortic valve (savr); this prolonged the hospitalization.The patient remained in the hospital.Approximately two and a half weeks after the savr, an x-ray of the chest showed small bilateral pleural effusions.No treatment was reported.
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Manufacturer Narrative
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The product analysis and investigation remain in progress.Following completion, if additional information is received a supplemental report will be submitted.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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Correction: b3: date of event; e3 initial reporter first name and occupation; g3: date mfr rec; updated data: a1: pt.Identifier; a4: weight in lbs; g2: report source; h6: annex e, annex a, annex f.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted. 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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Additional information was reported that 6 years, 1 month, and 20 days following the implant of this transcatheter bioprosthetic valve, the patient was admitted to the hospital.Shortness of breath related to acute on chronic congestive heart failure (chf) was experienced.Pulse oximeter was 91% on room air and was placed on 2 liters of oxygen via nasal cannula.Oxygen level increased to 98%.B-type natriuretic peptide (bnp) results 858.0 picogram per milliliter (pg/ml).Furosemide was administered.Testing revealed an issue with the valve.Computed tomography (ct) images showed moderate bilateral pleural effusion in the setting of aortic valve disease.Transthoracic echocardiogram (tte) showed a peak aortic gradient of 125 millimeters of mercury (mmhg) and a mean gradient of 7mmhg.Echocardiogram performed approximately 8 months prior showed a well seated valve with a peak aortic gradient of 13.97mmhg and a mean gradient of 75mmhg.Chest x-rays were performed three days after presenting and revealed trace pleural effusion and development of mild pulmonary edema.A repeat tte was performed and showed an ejection fraction (ef) of 65% with a possible prolapse of the aortic valve.Tee showed a well seated aortic valve, with a peak aortic gradient of 17.64mmhg and a mean gradient of 9.68mmhg, with moderate to severe aortic regurgitation.Peak velocity was 2.2 meters per second (m/sec), a mean gradient 9mmhg and an effective orifice area (eoa) of 2.0 cm2.Prior to the valve-in-valve procedure, imaging showed dark regions near the valve¿s non-coronary cusp (ncc) that were possibly pannus or thrombus.Calcification near the valve frame in the right coronary cusp (rcc), lcc and ncc at approximately 4.7 millimeter (mm) above the inflow.Calcification was near the proximal right coronary artery (rca).Protruding calcification under the lcc extended into the left ventricular outflow tract (lvot) and was under the ncc.Calcium under the rcc extended approximately 1.8mm below the inflow.
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Manufacturer Narrative
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Updated data: b5, d6b, h3, h6 - annex b and annex c analysis: the device was received inside a heart valve return kit jar filled with clear 0.2% glutaraldehyde solution.Visual evaluation of returned device showed that all leaflets were tan and flexible except where calcification was present.One leaflet appeared intact.Signs of leaflet wear was noted along the margin of attachment of the second leaflet approaching commissure.Calcification nodules were present on the shoulder of the second leaflet approaching the commissure with notable leaflet deterioration.Leaflet deterioration appeared to be associated with visible calcification.An approximate 10mm tear was observed on the third leaflet near the commissure.The tear extends along the stitchline.An approximate 10mm tear was observed on third leaflet near the commissure.The adjacent manufacturing sutures appeared intact.Commissure was thinly encapsulated with glistening off-white pannus, appeared intact.Second commissures and third commissure appeared intact.The first and second leaflet were in the closed position with leaflet 3 open towards the frame wall.Thick, tan pannus adhered to the valve skirt.Minimal off-white pannus adhered to the outflow crown.Thick, off-white pannus lined the inflow crown and extended into the inner lumen.Radiography revealed calcification on one of the leaflets and outer wall.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 reported that following the implant of the non-medtronic (livanova-perceval) sav, echocardiogram showed a mean gradient of 4mmhg and no pvl.
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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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Event Description
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Additional information received indicated that 2 units of packed red blood cells were required as related to the valve replacement surgery.
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Manufacturer Narrative
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Updated data: h6 - annex b, annex d conclusion: review of the device history review (dhr) for this device (serial number (b)(6)) found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.No valve implantation procedure images were available for medtronic review.Prior to the valve-in-valve procedure, imaging showed dark regions near the valve¿s non-coronary cusp (ncc) that were possibly pannus or thrombus.Several factors could affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditions, and its presence and rate of formation is largely dependent on patient condition.A conclusive root cause could not be determined.6 years following implant, a cuspal tear was noted per transesophageal echocardiogram (tee) and computed tomography (ct) scan.One potential cause of cuspal tears is the use of an oversized balloon for post-balloon aortic valvuloplasty (bav).Per the device instructions for use (ifu), if 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.No imaging is available to confirm the size of the post-bav; thus, a conclusive root cause of the cuspal tear could not be determined.The leaflet deterioration associated with calcification noted in the returned product analysis and the initially reported severe calcifications were likely contributing factors.Calcification is a recognized failure mode of bioprosthetic valves.Several factors could contribute to the onset and propagation of structural valve dysfunction, including calcification, such as patient medical history (age, disease stage, comorbidities), pharmacological factors, and/or intrinsic properties of the valve itself.A conclusive root cause could not be determined.Of note, the patient had pre-existing moderate mitral annular calcification.High gradients can be related to valve related factors (degeneration, thrombus, calcification) or non-valve related factors (lvot obstruction, patient pressures, lv dysfunction).Regurgitation could be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Ct images showed moderate bilateral pleural effusion in the setting of aortic valve disease.Effusion is a known effect that can occur after cardiac procedures due to procedural complications.Bleeding is a known potential adverse effect per the device ifu and could occur during the implant procedure, with a varying risk that is dependent on several factors such as the access point for the implant, the patient's state of health, and pre-existing medical conditions.The issue is commonly resolved through a blood transfusion or provision of packed red blood cells (prbcs).Heart failure is listed in the device ifu under potential adverse events, and could be related to several factors (procedure, patient comorbidities).A conclusive root cause for the high gradients, regurgitation, effusion, bleeding, and heart failure could not be determined without imaging for medtronic review.However, the reported calcifications and cuspal tear leading to valve failure were likely root causes.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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