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

Model Number EVOLUTPRO-23

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 07/01/2022

Event Type  Death  

Manufacturer Narrative

Product analysis: the device remains implanted, 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.Select patient information cannot be included in regulatory report due to regional privacy regulations.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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

Medtronic received information that two years, seven months, and twenty-two days following the implant of this transcatheter bioprosthetic valve, the patient was hospitalized due to heart failure.Three days later, dialysis was introduced due to worsening of cardiac function.Intraductal papillary mucinous neoplasm (ipmn) was suspected.It was reported that due to senectus (progressive atrophy of the aged), detailed examination and surgery were not performed.Approximately three years post-implant, the patient died.The cause of death was unknown.Per the physician, the valve and the valve implant procedure contributing factors to the patient's death were unknown.

Manufacturer Narrative

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.A medical safety assessment was performed.Based on the information provided, and as indicated in the event description, it is likely that the harm of heart failure contributed to the need for dialysis.However, it is unlikely that the harm of death was related to the valve, but rather was related to worsening of cardiac function due to congestive heart failure.Heart failure is listed in the device instructions for use (ifu) under potential adverse events, and can be related to several factors (procedure, patient comorbidities, etc.).Based on the limited information available, the heart failure could be contributed to the need for dialysis.A procedure- or valve-related death is an inherent risk when the patient condition is such that a transcatheter aortic valve (tav) is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.With the limited information available and the medical safety assessment, a conclusive root cause could not be determined.The patient death was likely due to worsening of cardiac function caused by congestive heart failure, and unlikely related to the device.This event does not indicate device misuse or malfunction.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 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: 16452792
• MDR Text Key: 310344991
• Report Number: 2025587-2023-00719
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: EVOLUTPRO-23
• Device Catalogue Number: EVOLUTPRO-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Date Device Manufactured: 03/05/2019
• 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