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	09/19/2023
Type of Reportable Event	Malfunction
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 in its original product packaging.The valve in its original jar fully submerged in clear unknown solution.The valve was discolored showing evidence of blood contact.All leaflets were flexible and intact.Creases were found on all leaflets.: as received, all leaflets appeared partially closed with a large gap between the free margins.Remnant, bloody coagulated tissue noted on top of commissure 3-1.All commissures were intact.The valve was placed in a cold saline bath to perform loading simulation per appropriate instructions for use (ifu).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 to complete the loading simulation; no visual or tactile anomalies were noted.The valve was then deployed in a warm saline bath to perform deployment simulation.The deployment knob was rotated to expose the valve at the inflow; no anomalies were observed.The valve continued to be deployed up to the point of no recapture; no anomalies were observed.The valve was fully deployed; no anomalies were noted during the complete deployment of the valve.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 during the implant of this transcatheter bioprosthetic valve, the valve was constrained at 80% release.The valve and delivery catheter system (dcs) were removed, and a pre-implant balloon aortic valvuloplasty (bav) was performed.The valve and dcs were replaced to complete the procedure.No adverse patient effects were reported.

• 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: 21114127
• Report Number: 2025587-2025-00225
• Device Sequence Number: 21022800
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: 00763000370688
• 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: 2023
• Device Explanted Year: 2023
• 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): 01/09/2025

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: 06/16/2025
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 01/09/2025
• Date Device Manufactured: 06/17/2023
• 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: 89 YR
• Patient Sex: Male