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

Model Number EVOLUTR-34-US

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Hypoxia (1918); Myocardial Infarction (1969); Cardiogenic Shock (2262); Respiratory Failure (2484); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/19/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made 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 during implant of this transcatheter bioprosthetic valve, the valve was successfully deployed on the initial deployment attempt.The position was excellent.Mild paravalvular leak (pvl) was reported at the mitral/aortic continuity.The valve was expanded using a 28 mm ture balloon at high pressure to remedy the mild pvl/ the patient remained stable throughout the entire implant procedure and no complications were reported.Hemostasis was achieved using perclose sutures and the final mean aortic valve gradient was zero.Approximately two years following this implant, the patient was admitted to the hospital with central aortic insufficiency (ai).Little calcium on the valve leaflets was also reported.Previous echocardiograms did not show this ai.The patient was brought back for a valve in valve procedure using a non-medtronic (edwards sapein 3) valve.During the non-medtronic valve deployment, the coronary arteries were occluded.The team elected to preform an open valve replacement.The non-medtronic sa pien valve and medtronic evolut transcatheter valves were subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

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 directly from the physician, which reported that the non-medtronic sapien valve was implanted in the midst of an emergency as a prior computed tomography (ct) was not performed.It was reported that during the surgery, the top of the non-medtronic sapien valve was above the sinotubular junction (stj).As the coronary arteries were lower than the top of the stj, an immediate coronary occlusion occurred dur to the creation of the tube graft.

Manufacturer Narrative

Updated b2.Updated b5.Updated d9.Updated h1.Updated h6.The product analysis of the returned product and investigation are in progress.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 which reported that the echocardiogram approximately two years following the implant showed severe ai.The cause of the ai was unknown.As a result, the patient presented with massive sub-sternal chest pain, shortness of breath, and an non-st segment elevation myocardial infarction (nstemi).It was reported that the initial troponin levels were negative, but rapidly increased.It was reported that the open surgical explant and replacement were not successful.The patient died following the repair procedure.The cause of death was not reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received via fedex inside a hospital specimen jar filled with cloudy 10% formalin solution.All leaflets appeared tan and pliable.An approximate 7mm tear was noted on the margin of attachment of leaflet 1 extending towards the nadir.An additional smooth tear was noted on the belly of leaflet 1 suggestive of possible damaged occurred during excision.Leaflets 2 and 3 were excised.A native loose tissue was also returned.A native loose tissue was also returned.Layer of off-white pannus encapsulated all commissures; unable to assess condition.Coaptation: due to the received state, coaptation cannot be assessed.Adherent thick layer of glistening off-white pannus observed on the inflow crown extending into the inner lumen.Adherent off-white pannus noted on the outer surface of the skirt extending.Thick, off-white pannus noted along approximately half of the outflow crown circumference.Unknown amount of pannus may have been removed during explant.Multiple struts appeared damaged (broken) on the outflow frame possibly from the excision procedure.Conclusion: 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.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions, and a conclusive cause could not be determined from the limited information available.A mild pvl has minimal impact on the patient and is generally deemed an acceptable residual condition.In this case, the valve was expanded using a 28 mm true balloon at high pressure to remedy the mild pvl.Post-implant occurrence of aortic regurgitation after an extended time period can be caused by a variety of factors, including changes to patient anatomy or pre-existing medical conditions.Based on the medical safety assessment, aortic insufficiency is assessed as possibly related to the evolut r per the valve product analysis, which shows both acute and chronic damage related to overexpansion of the tav related to post-implant dilatation (pid).However, it is difficult to ascertain whether the ¿chronic¿ damage observed could have happened as result of the sapien 3 device that was deployed into this valve immediately prior to explant or pid at the original time of implant.With limited information available, a conclusive cause could not be determined.As a result, the patient presented with massive sub-sternal chest pain, shortness of breath, and a non-st segment elevation myocardial infarction (nstemi).It was reported that the initial troponin levels were negative, but rapidly increased.Myocardial infarction/cardiac enzyme elevation is a known potential adverse effect per the device instructions for use (ifu).It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally functioning device or model implant procedure.With limited information available, a conclusive cause of the infarction/cardiac enzyme elevation could not be determined.Cardiac arrest and cardiogenic shock are a known potential adverse effect per the ifu.Unfortunately, a relationship of the reported cardiac arrest and cardiogenic shock to the device or procedure could not be determined with the limited information available.A procedure- or valve-related death is an inherent risk when the patient condition is such that a pav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.It is unknown if an autopsy was performed.A conclusive assessment of the relationship between the event and the device could not be reached.No allegations were made against the device, and there was no indication that a malfunction or misuse contributed to the reported events.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

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.

Event Description

Additional information was received that the patient died 3 years, 11 months and 2 days following the initial implant of the transcatheter bioprosthetic valve.No complications occurred while performing the open surgical repair.The cause of death was noted to be cardiac arrest, acute respiratory failure with hypoxia, cardiogenic shock and severe aortic insufficiency.

• 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: 16141257
• MDR Text Key: 307124272
• Report Number: 2025587-2023-00096
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017682
• UDI-Public: 00763000017682
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/23/2023

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: 09/05/2020
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/07/2023; 02/07/2023; 02/16/2023; 03/21/2023
• Supplement Dates FDA Received: 02/08/2023; 02/08/2023; 03/07/2023; 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 78 YR
• Patient Sex: Male