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

Model Number EVPROPLUS-26US

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

Patient Problems Abscess (1690); Fever (1858); Pain (1994); Cognitive Changes (2551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2022

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.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 9 days following the implant of this transcatheter bioprosthetic valve, fever and femoral pain were observed.No treatment was reported.10 days following the valve implant, impaired consciousness and fever were observed and the patient was hospitalized.12 days following the valve implant, sepsis, disseminated intravascular coagulation (dic) and multi-organ failure were observed.Transcatheter paravalvular abscess was observed and medical treatment was continued.The patient was high risk for surgical treatment and the patient's family did not consent to surgical treatment.There was difficulty controlling the infection and the patient passed away.The cause of death was not reported.

Manufacturer Narrative

Conclusion: no images were provided to medtronic, so no image review could be performed.This event was reviewed by medical safety team.The excerpt of the medical safety subject matter expert (sme) review report follows: the reported transcatheter aortic valve (tav) paravalvular abscess, 9 days post index procedure, was assessed.Upon review of the information provided, the primary event of tav paravalvular abscess, leading to death, is assessed as likely related to the evolut pro+ as a paravalvular abscess was noted on the pro+ valve with signs of infection and sepsis including fever, disseminated intravascular coagulation (dic) and multi-organ failure (mof).However, endocarditis was not confirmed in the data provided.Endocarditis/infection and death are known potential risks associated with the implantation of the evolut pro+ valve and all reported aes and appropriate severities are documented in the risk management files and instructions for use.Endocarditis/infection cases that occur within two months after the procedure are known as early prosthetic-valve endocarditis and are usually acquired while the patient is in the hospital (nosocomial infection).These cases may also be due to introduction of the microorganism during the implant procedure.Based on the limited available information, a conclusive relationship between the device and the endocarditis cannot be determined, but it is unlikely that the endocarditis is attributed to the device or the manufacturing process.The patient was high risk for surgical treatment and the patient's family did not consent to surgical treatment.There was difficulty controlling the infection and the patient passed away.The cause of death was not reported.It is unknown if an autopsy or explant was performed.With the limited information available, a relationship between the device and the death could not be established.The device history record (dhr) and sterility record were reviewed and showed that this device met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.This event does not indicate device misuse or malfunction.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: 16145185
• MDR Text Key: 307156400
• Report Number: 2025587-2023-00102
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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: 02/26/2024
• Device Model Number: EVPROPLUS-26US
• Device Catalogue Number: EVPROPLUS-26US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/15/2023
• Date Device Manufactured: 02/26/2022
• 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; Hospitalization