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

Model Number EVOLUTR-34-C

Device Problems Calcified (1077); Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Angina (1710); Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); Regurgitation, Valvular (2335); Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was returned, and device evaluation anticipated but not yet begun.Conclusion: the investigation is in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that three years six months and twelve days following the implant of this transcatheter bioprosthetic valve, the patient had symptoms and aortic insufficiency.The patient was scheduled for a transcatheter aortic valve replacement (tavr) and the valve was found to have a torn leaflet.The physician stated that the valve was post dilated three times with a 25 millimeter (mm) balloon at the initial tavr implant.Subsequently, the valve was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

B5: additional information was received that during the implant procedure of this transcatheter bioprosthetic valve a 22 millimeter (mm) non-medtronic balloon was used for the aortic valvuloplasty (bav).Further, six months following the implant of this transcatheter valve, a transesophageal echocardiogram (tee) revealed mild to moderate paravalvular leak (pvl).One year after the implant, a transesophageal echocardiogram (tee) indicated moderate regurgitation.One year, two months, and twenty-nine days following the implant of the valve, transthoracic echocardiogram (tte) showed mild aortic insufficiency (ai) with a peak velocity of 2.8 meter per second (m/s).Approximately one year, six months, and twelve days post transcatheter valve implant a tte noted normal left ventricular chamber size with increased wall thickness and a preserved function with left ventricular ejection fraction of 65%.The transcatheter valve had mild ai and peak velocity 2.8m/sec with mean gradient 14mmhg.Two years and five days following valve implant, tee indicated moderate central aortic regurgitation, and that the pvl had reduced to trace.No treatment reported to this timeframe.Two years five months, and five days following valve implant, an echocardiogram showed central valvular aortic regurgitation.It was noted the leaflets of the valve appeared to have deteriorated and were severely regurgitant.Two days later, the patient underwent a left heart catheterization via right femoral access; severe aortic insufficiency was diagnosed.Approximately three years and three months post valve implant moderate central leak and pvl was present and no symptoms presented.Approximately three years and five months following valve implant angina presented.Three years, six months, and twelve days following valve implant, severe central leak and pvl due to leaflet failure required the valve to be explanted and replaced with a surgical aortic valve.The transcatheter aortic valve (tav) was found to be densely fibrosed to the aortic wall and native valve.The ai was reported to be due to a partial tear of the non-coronary (nc) leaflet at the coronary ostia of the nc and right coronary (rc) cusps.Heavy calcification was identified in the aortic root, annulus and the mitral valve.As reported, the physician had thought the torn leaflet could have been the result of the initial post dilation of the valve but it was unsure.Following the implant of the surgical valve, the left ventricle systolic function (lvsf) improved and resulted in no residual pvl.No additional adverse patient effects were reported.Updated data: a4, e4, h6 patient and device codes corrected data: e1.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.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the device was received submerged in clear 0.2% glutaraldehyde solution.Thick circumferential off-white pannus remained attached to the outflow frame.The outflow frame appeared distorted with an elliptical-shaped.All leaflets were tan-brown, slightly stiff yet flexible except where host tissue extended from the inflow and outflow.There was an approximate 10 millimeter (mm) tear leaflet on leaflet 2 adjacent to the margin of attachment with remnant tissue near commissure 2.The manufacturing sutures on the margin of attachments were noted to be intact.Adjacent folds on the leaflet may have been attributed to the leaflet tear.The leaflet tissue appeared textured and frayed along the tear.Leaflet 2 and leaflet 3 appeared in the closed position with a gap between their free margins.Leaflet 1 was open towards to the frame wall.Off-white pannus appeared to thinly encapsulate commissures 1.Commissure 2 appeared intact.A strand of off-white pannus partially covered commissure 3; commissure appeared intact.From the inflow aspect, thick, glistening off-white pannus adhered to the inflow crown tips extending 1-15mm into the luminal surface.Multi-focal tan pannus adhered to the abluminal surface of the skirt extending to the margin of attachment of all leaflets.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.An unknown amount of pannus may have been removed during explant.Two bends on the outflow crown were observed.This damage likely occurred during valve explant attributed to tools used during explant, such as forceps.Radiography did not reveal calcification on the returned valve.Conclusion: a review of the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.No issues were noted that would have impacted this event.Images were submitted and the review showed no images of a post balloon aortic valvuloplasty (bav) for the transcatheter aortic valve (tav) implant.There appeared to be color flow differences around the aortic position in the 3-year echocardiogram, but no definitive conclusion could be determined.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 regurgitation was reported to be due to a partial tear of the non-coronary (nc) leaflet at the coronary ostia of the nc and right coronary (rc) cusps.The presence of the tear was confirmed during the returned product analysis.Calcification is a bioprosthetic valve failure that is patient influenced.As calcium deposits form on the valve, this 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 not confirmed from radiography of the valve during the product analysis.Therefore, the cause of the reported calcification could not be conclusively determined.In the evolut r instructions for use (ifu), calcification is also listed as a potential adverse event associated with the implantation of the valve.Per the device ifu, if valve function or sealing is impaired due to excessive calcification or incomplete expansion, a postimplant balloon dilation of the bioprothesis 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.As reported, the physician had thought the torn leaflet could have been the result of the initial post dilation of the valve, but the provided imaging could not confirm that.Thus, a conclusive root cause could not be determined at this time.There was no information to suggest a device quality deficiency that may have caused or contributed to this event.Updated data: d8, g1, h6 patient annex e, annex f, 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.

Manufacturer Narrative

Additional information was received that following the implant of this transcatheter bioprosthetic valve, the discharge echocardiogram showed a gradient of 11 mmhg and mild pvl.The echocardiogram was reviewed by core lab and assessed the gradient as 10.5 mmhg and the pvl as trace.No additional adverse patient effects were reported.Updated data: b5, b7 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 DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10744000
• MDR Text Key: 213435195
• Report Number: 2025587-2020-03248
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2019
• Device Model Number: EVOLUTR-34-C
• Device Catalogue Number: EVOLUTR-34-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 02/08/2021; 04/21/2021
• Supplement Dates FDA Received: 11/12/2020; 03/02/2021; 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 107