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

Model Number	EVOLUTFX-23
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve, the valve would not fully expand.The valve was withdrawn from the patient and deployed in warm saline, however, the valve continued to not fully expand.A different valve was used to complete the procedure.No adverse patient effects were reported.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.Product analysis: upon receipt of the suspect complaint device at medtronic¿s quality laboratory, visual analysis showed the device was received via fedex inside its original packaging and jar filled with clear unknown solution.The valve skirt appeared to be in partially crimped state.All leaflets were flexible and appeared intact.Coaptation: all leaflets appeared partially twisted in the closed position.All commissures were intact.The valve was submerged in warm saline to reset valve frame.The valve was then placed in a cold saline bath to perform loading simulation per instructions for use.Upon loading, both frame paddles appeared seated within the paddle attachment pockets.The capsule was advanced covering the frame paddles and outflow crown struts.The capsule was advanced until the capsule guide tube covered the commissure pad of the valve.The inflow cone was advanced to crimp the inflow portion of the valve.The capsule was fully advanced over the valve; no visual or tactile anomalies were noted.To simulate the reported event, the valve was deployed in a warm saline bath.The deployment knob was rotated to expose the valve.The valve continued to be deployed up to the point of no recapture; no anomalies were noted.The valve was fully deployed and appeared to exhibit a complete dilation; no anomalies were observed.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.

• Brand Name: EVOLUT FX 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: 21102141
• Report Number: 2025587-2025-00170
• Device Sequence Number: 18430471
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: 00763000370688
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/08/2025

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: 07/31/2024
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: 73 YR
• Patient Sex: Female