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

Model Number	EVOLUTR-26-US
Medical Device Problem Codes	Gradient Increase (1270); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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 or Problem Description
Medtronic received information that following the implant of this transcatheter bioprosthetic valve into a patient with an existing medtronic surgical tissue valve, the mean gradient across the mitral valve measured 11mmhg without any obvious mitral regurgitation(mr).Difficulty to assess via echocardiogram (echo) was reported.Ejection fraction (ef) measured 36%.It was reported the patient had an excellent recovery.Twenty-eight days post implant, a follow up echo showed an ef of 56% with a mean gradient across the mitral valve of 10mmhg.Again, the severity of the mr was difficult to assess.It was noted the patient felt much better; however, the patient developed heart failure symptoms.Five months and eight days later, another follow up echo was performed showing a mean gradient across the mitral valve of 13mmhg.Moderate-severe mitral regurgitation was observed.The mean gradient across the patient¿s aortic valve was stable at 24mmhg with no significant perivalvular leak.Due to the patient¿s progressive symptoms and bioprosthetic mitral valve failure, the physician chose to perform transseptal transcatheter mitral valve replacement and considered the patient to be at high risk for redo mitral valve surgery.Subsequently, six months and twenty-five days post implant, a third non-medtronic (edwards) valve was implanted successfully.No adverse patient effects were reported.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Common Device Name: 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: 21147916
• Report Number: 2025587-2025-00339
• Device Sequence Number: 9190275
• Product Code: NPT
• UDI-Device Identifier: 00763000017668
• UDI-Public: 00763000017668
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2020
• Device Model Number: EVOLUTR-26-US
• Device Catalogue Number: EVOLUTR-26-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 01/14/2025
• Date Device Manufactured: 02/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 72 KG