MAUDE Adverse Event Report: Medtronic Ireland EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-2329
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a non-medtronic transcatheter valve revision procedure via the left femoral access, a balloon valvuloplasty of the non-medtronic valve was first performed.The first medtronic delivery catheter system (dcs) attempted to place the valve two times.However, the valve dislodged with both attempts.The dcs recaptured the valve, and this system was removed from the patient.A new valve was loaded onto a new dcs system.With the first two valve placement attempts of this new system, the valve was positioned low which required valve captures.On the third placement attempt the valve dislodged.This dcs system recaptured the valve, and this system was removed from the patient.Another new valve was loaded onto a new dcs system.Upon the first valve placement attempt with this new system, the valve dislodged.The valve was recaptured and then was successfully deployed and implanted.A balloon valvuloplasty was not performed between the new system uses.As reported, there were no patient symptoms or patient related complications as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id evfxplus-26; product lot/serial number(b)(6); product type: heart valve implant date (b)(6)2026; explant date n/a product id l-evolutfx-2329; product lot/serial number unknown; product type: compression loading system; implant date n/a; explant date n/a 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 DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer (Section G): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50145769
• Report Number: 9612164-2026-03936
• Device Sequence Number: 9349656
• Product Code: NPT
• UDI-Device Identifier: 00763000942700
• UDI-Public: (01)00763000942700(17)280120(10)0012967614(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012967614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 01/20/2026
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 182 LB
• Patient Race: White