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

Model Number EVOLUTR-29

Device Problems Failure to Advance (2524); Activation Failure (3270)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 02/27/2023

Event Type  Death  

Manufacturer Narrative

Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: envpro-14, serial/lot #: (b)(4), ubd: 31-oct-2024, udi#: (b)(4).Product analysis: the valve remains implanted and the dcs was discarded, 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 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 the implant of this transcatheter bioprosthetic valve, a pre-dilatation was performed with a 22 millimeter (mm)  non-medtronic balloon (vacs).Moderate to severe aortic insufficiency was observed.The delivery catheter system (dcs) was advanced but unable to cross the native valve.A snare was used to guide the dcs through the native valve.During this time, the patient had neurological limitations as they stopped responding to questions.The valve was released and was not fully expanded.The valve was post dilated with a 24 mm non-medtronic balloon (vacs).After the post dilation, the patient was asystolic and was paced.After the valve implant procedure the patient was taken out of the room and developed ventricular fibrillation.The patient was reanimated for about 20 minutes but without success.Subsequently the patient died.

Event Description

Additional information was received that during the valve implant, the post-implant dilation did not fully resolve the valve expansion due to the calcification.Per the physician, the cause of death could not be confirmed and the valve did not cause or contribute to the death.

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.

Manufacturer Narrative

Conclusion: the device history record was reviewed for the valve and delivery catheter system (dcs) and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Images were submitted to medtronic for review.Patient appears to have severe calcification on the leaflets, pre balloon aortic valvuloplasty (bav) was performed accordingly with the anatomy of the patient, during the deployment it can appreciate under expansion of the frame in the waist of the valve that could have generate severe paravalvular leak (pvl).Post dilatation was performed, however movie to evaluate the result was not provide.The events mentioned regarding ventricular fibrillation and the neurological limitations are not possible to evaluate with the images provided.This event was reviewed by medical safety team.The excerpt of the medical safety subject matter expert (sme) review report follows: the native valve was severely calcified likely causing severe pvl requiring the post-implant bav, therefore this would be related to the evolut r device with the native valve calcification as a contributing factor.However, it is unknown if the death is related to the device or dcs as imaging post implant dilatation were not available for review, but the site physician noted that the post-dilatation did not resolve the pvl however, per the physician, the cause of death could not be confirmed and the valve did not cause or contribute to the death.Aortic regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Based on the image review and medical safety assessment, native valve was severely calcified which may have been a contributing factor to the reported regurgitation.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.A snare was used to guide the dcs through the native valve.During this time, the patient had neurological limitations as they stopped responding to questions.The valve was released and was not fully expanded.It was then reported that the valve was released and was not fully expanded.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.In this case, the valve was post dilated with a 24 mm non-medtronic balloon (vacs).However, as reported, the post-implant dilation did not fully resolve the valve expansion due to the calcification.Ventricular fibrillation is generally a result of known potential adverse effects per the device ifu, such as conduction disturbances or hypertension, or an effect of certain medications or other pre-existing patient conditions.They are potential procedural complications associated with any cardiac or thoracic procedure, open or catheter-based, and can often be treated with medication.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.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: 16465264
• MDR Text Key: 310488064
• Report Number: 2025587-2023-00763
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Date Device Manufactured: 11/17/2022
• 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; Death
• Patient Sex: Female