MAUDE Adverse Event Report: MEDTRONIC IRELAND EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-2329
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a transcatheter aortic valve implant procedure, the delivery catheter system (dcs) was inserted into the patient and advanced to the native aortic annulus.The valve was then partially deployed in that it was positioned 2 millimeters (mm) from the non-coronary cusp (ncc) and 1-2 mm from the left coronary cusp (lcc).Prior to slowly withdrawing the dcs from the valve, the nosecone was centered within the valve frame by slightly retracting the guidewire.After retracting the guidewire, the valve was slowly deployed.As the valve was slowly deployed, and as the guidewire was in the left ventricle, the nosecone of the dcs interacted with the valve causing it to dislodge towards the patient's aorta.After valve dislodgement, the valve was positioned in that it was 0 mm from the ncc and -1 mm from the lcc.The attending physician then decided it would be best to implant a second transcatheter aortic valve.In response, a new valve was prepared and then was successfully implanted.Per the physician, the nosecone of the dcs and non-medtronic guidewire caused the valve to dislodge.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx plus valve; product id evfxplus-26 (b)(6); product type: 0195-heart valves; implant date (b)(6) 2026: explant date: n/a.H6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.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.
Additional Manufacturer Narrative
Additional codes.Annex f code was erroneously omitted from the initial medwatch.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
Additional information was received that the cusp overlap technique was used.The valve was not inadvertently deployed to an unintended position.Per the physician, there were no additional procedural observations, or anything in terms of patient anatomy that contributed to the dislodgement.
Additional Manufacturer Narrative
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 ; 091708096
• MDR Report Key: 24933331
• Report Number: 9612164-2026-02040
• Device Sequence Number: 5356866
• Product Code: NPT
• UDI-Device Identifier: 00763000942700
• UDI-Public: (01)00763000942700(17)280213(10)0013293847(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0013293847
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 05/18/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/18/2026; 06/12/2026
• Date Device Manufactured: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female