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

Model Number	D-EVOLUTFX-34
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Invagination (1336); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id l-evolutfx-34 product lot number implant date na explant date na this is a system report.The section d information is for the primary device, which was in use with the following: product id: evolutfx-34, serial/lot #: (b)(6), ubd: 14-mar-2027, udi#: (b)(4) 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
It was reported that during a transcatheter heart valve procedure, a pre-balloon dilation was performed with a 23 mm balloon.The valve was initially positioned too high and required partial recapture and repositioning.Upon recapture, the stiff wire was moved, causing the valve to dislodge up and necessitate a full recapture.During the second deployment, an infold was noted.The valve was recaptured and removed.A new valve was subsequently implanted.
Event or Problem Description
It was reported that during a transcatheter heart valve procedure, a pre-balloon dilation was performed with a 23 mm balloon.The valve was initially positioned too high and required partial recapture and repositioning.Upon recapture, the stiff wire was moved, causing the valve to dislodge up and necessitate a full recapture.During the second deployment, an infold was noted.The valve was recaptured and removed.A new valve was subsequently implanted.Additional information was received to report the patient anatomy included calcium on the annulus in the left coronary cusp; however, there was question whether the fellow pulled the guidewire and caused the valve to move during recapture, it was unknown if this contributed to the infold.There was a ten minute procedural delay as the new valve was loaded.
Additional Manufacturer Narrative
Updated data: b5.A second paragraph was added.Additional codes.An annex f code was added.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
Updated data: h2 h3 h6 image review: an incomplete set of intraprocedural fluoroscopic images were provided for review of the event.Patient¿s executive summary was not provided for anatomical review.The images available show the valve being deployed in an left anterior oblique (lao) view.The valve was deployed just prior to the point of no recapture and depth assessment was performed in the lao view only.The depth oscillated between 0 millimetres (mm) and 2mm on the non-coronary cusp and 5mm on the left coronary cusp.The valve was recaptured during which the valve dislodged aortic.Upon complete recapture of the valve infolded and the infold was confirmed during the subsequent deployment attempt.The infold is characterized by an inward fold or crease in the valve, extending from the inflow.Infolding could occur due a misloaded valve, anatomical characteristics such as calcium, and recaptures.According to medtronic best practices, if an infold is identified, the valve should be recaptured, removed from the body, and discarded.New sterile components must be used.It was reported that the valve was recaptured, and a new valve was used to complete the procedure.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
Updated data: h6 - annex b and annex c codes as they apply to the system reported device 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
Updated h.6.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: 22612407
• Report Number: 9612164-2025-03644
• Device Sequence Number: 5494260
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)261106(10)0012526064(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/14/2025

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 Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012526064
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 07/27/2025; 08/08/2025; 08/18/2025; 10/11/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/13/2025; 09/10/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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 Sex: Male
• Patient Weight: 70 KG