MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTR-26-C

Device Problems Degraded (1153); Gradient Increase (1270); Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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.

Event Description

Medtronic received information that prior to the transcatheter valve implant the mean gradient at baseline was 38 millimeters of mercury (mmhg).At discharge the mean gradient was 4.4 mmhg and a peak velocity of 1.3 m/sec.As reported, the lowest depth at implant was the non-coronary cusp (ncc) at 11mm and lower than the left coronary cusp (lcc).Approximately five years following the valve implant, a transthoracic echocardiogram (tte) measured an aortic mean gradient of 13 mmhg and a peak velocity 2 m/sec.Approximately 6 years and 10 months following the valve implant, mild stenosis of the valve was identified.Approximately seven years and one month following the implant of this transcatheter bioprosthetic valve, the patient presented with mild dyspnea during a routine follow-up visit.A tte measured an ejection fraction of >50%, an increased aortic valve gradient of 36.9 mmhg, and peak aortic velocity of 3.96 m/sec, a velocity time integral across the aortic valve of 93.7 cm, peak left ventricular outflow tract (lvot) velocity of 0.71 m/sec, a velocity time integral of the lvot velocity of 18.1 cm, a mean lvot gradient of 1 mmhg, and a velocity ratio (v1/v2) of.18.Moderate paravalvular leak and mild stenosis of the prosthetic valve were noted.Total aortic regurgitation grade of moderate reported.Mild mitral regurgitation and trace tricuspid regurgitation were also noted.As reported, leaflet thickening and thrombus were not evident.Treatment was not reported.Approximately a month later, a computed tomography angiogram of the chest revealed mild tri-leaflet hypoattenuating leaflet thickening.The greatest involvement was the leaflet in the posterior position which demonstrated restricted leaflet motion.As result, a transcatheter aortic valve replacement, valve-in-valve procedure, was performed.No additional adverse patient effects were reported.

Manufacturer Narrative

Added h6 ime coding.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.

Manufacturer Narrative

Conclusion: review of the device history record (dhr) for this valve was performed and all process parameters were within specification as outlined in applicable procedures and specifications.All materials used were as per the requirements of the dhr.All processes were carried out as per relevant procedures and met specification.The valve was not returned to medtronic for product analysis.Images were submitted and reviewed.Transthoracic echo (tte) images provided with suboptimal image quality.The tte showed a normal ef of 60%.The evolut implant appeared deep.Heavy prosthetic leaflet thickening with decreased excursion was noted.Mild mitral regurgitation (mr) and trace tricuspid regurgitation (tr) was also noted.Mild to moderate paravalvular leak (pvl) was seen on the anterior side of the evolut frame.A mean atrio-ventricular (av) gradient of 36 millimeters of mercury (mmhg), a peak av velocity of 4.1 m/s, and a velocity ratio of 0.18 were measured.These doppler findings suggested severe prosthetic stenosis.Stenosis is a known potential adverse effect per the evolut instructions for use (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.Pvl can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.With information available, a conclusive root cause could not be determined.High gradients can be related to valve related factors (degeneration, thrombus, calcification, etc.) or non-valve related factors (left ventricular outflow tract (lvot) obstruction, patient pressures, left ventricular (lv) dysfunction, etc).With the information available, a conclusive root cause could not be determined but the stenosis was a likely contributing cause.Mitral regurgitation post aortic transcatheter implant can potentially be caused by patient anatomical and procedural factors, where the implant depth may cause impingement to the mitral valve/apparatus, potentially leading to a compromised mitral valve function.In this case, the valve appeared deep during the image review and the lowest reported implant depth was 11 millimeters at the non-coronary cusp (ncc), which was significantly below the ifu-recommended target depth range of 1 to 5mm.Thus, this low implant position was a likely contributing cause of the mitral regurgitation.Tricuspid regurgitation was reported but as the evolut r valve is implanted in the aortic position, there is no opportunity for an aortic valve to impinge on a tricuspid valve, which are on opposite sides of the heart.With the information available, a conclusive root cause could not be determined, but the evolut valve was likely not related to the tricuspid regurgitation.Hypoattenuated leaflet thickening (halt) can be a manifestation of structural valve dysfunction (e.G.Calcification).Several factors can contribute to the onset and propagation of this 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.Poor valve coaptation is a known potential adverse effect per the device ifu.With the information available, a conclusive cause could not be determined, but the halt (which image review confirmed the presence of heavy prosthetic leaflet thickening with decreased excursion) may have been a contributing cause of the reported mild tri-leaflet hypoattenuating leaflet thickening.As result, a transcatheter aortic valve replacement, valve-in-valve procedure, was performed.There was no information to suggest a device quality deficiency that may have caused or contributed to this.Updata data: h6 medthod, result, 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.

Event Description

Additional information was received that indicated that the event was resolved following the transcatheter aortic valve replacement.

Manufacturer Narrative

Updated data: b5 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.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16031000
• MDR Text Key: 305975336
• Report Number: 2025587-2022-03676
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2015
• Device Model Number: EVOLUTR-26-C
• Device Catalogue Number: EVOLUTR-26-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Date Device Manufactured: 10/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG