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

Model Number EVOLUTFX-29

Device Problem Central Regurgitation (4068)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/11/2024

Event Type  Death  

Manufacturer Narrative

Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that 19 days following the implant of this transcatheter bioprosthetic valve, the patient was sick and had severe mitral valve regurgitation.Subsequently, the patient died.The cause of death was unknown.Per the physician, the death was not related to the valve.

Manufacturer Narrative

Updated data: a3b - gender b5 - event description medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that the patient had moderate to severe mitral regurgitation and was planned to have a mitraclip procedure following recovery from the transcatheter aortic valve replacement (tavr).Per the physician, the valve did not cause or contribute to the mitral regurgitation.

• Brand Name: EVOLUT FX 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: 18951912
• MDR Text Key: 338265148
• Report Number: 2025587-2024-01828
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: 00763000370701
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Date Device Manufactured: 12/12/2023
• 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: 78 YR
• Patient Sex: Female