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

Model Number EVPROPLUS-23US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Insufficient Information (4580)

Event Date 10/17/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: no product was returned and no procedural images were submitted for review; therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 prior to the implant of this transcatheter bioprosthetic valve, into a patient with an existing non-medtronic valve, it was noted that the patient was a high risk of sinus sequestration.During attempted implant, the valve was deployed to 80% and a leaflet of the non-medtronic valve was noted to be above the level of the sinotubular junction.The valve was not implanted.The physician chose to abort the procedure due to risk of sinus sequestration.Subsequently, the patient died.The cause of death was not reported; no further information was provided.

Manufacturer Narrative

Additional information was received that the cause of death was noted to be severe bradycardia, hypotension, and cardiogenic shock.Per the physician, the patients death was not related to the valve or the delivery catheter system (dcs).H6.Patient 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 the patient died after the implant procedure due to severe bradycardia.Cardiopulmonary res uscitation (cpr) was attempted to resuscitate the patient.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 valve was not returned to medtronic for product analysis.Images were submitted to medtronic for review.The image review contained one image and the patient summary.The image showed the ¿white line sign¿ of the surgical, non-medtronic valve leaflet extending past the left coronary artery as reported.Patient summary measurements are not centered and the valve to coronary distances are not measured according to best practices therefore cannot be brought into review for comment.Conduction disturbances, such as bradycardia, are known potential adverse effects per the device instructions for use (ifu) and can be resolved with the implant of a permanent pacemaker with the risk-benefit ratio in favor of the tav.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations.Hypotension is a known potential adverse effect per the device 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.The image review report of the non-medtronic valve leaflet extending past the left coronary artery indicates that sinus sequestration may have been a contributing cause to the hypotension.Heart failure (of which cardiogenic shock is a form) is listed in the device ifu under potential adverse events, and can be related to several factors (procedure, patient comorbidities, etc.).The reported bradycardia may have been a contributing cause.The cause of death was reported as severe bradycardia.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a tav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.With the limited information available, a conclusive relationship between the device and the death could not be established, but there was no evidence to suggest that the valve or its function contributed to the patient¿s death and per the physician, the patient¿s death was not related to the valve or the delivery catheter system (dcs).Review of the device history record (b)(6) for this device was performed.Based on the dhr review, 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.Updated h6.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 PRO PLUS 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: 15741243
• MDR Text Key: 303133733
• Report Number: 2025587-2022-03085
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211103
• UDI-Public: 00763000211103
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2023

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: 05/29/2024
• Device Model Number: EVPROPLUS-23US
• Device Catalogue Number: EVPROPLUS-23US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/06/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 12/16/2022; 05/05/2023
• Supplement Dates FDA Received: 12/13/2022; 01/11/2023; 05/07/2023
• Date Device Manufactured: 05/30/2022
• 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): Death
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 133 KG