MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-26
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the attempted implant of a transcatheter aortic valve into an indwelling non-medtronic surgical aortic valve (sav), the valve was successfully positioned at 2 millimeters (mm) on the non-coronary cusp (ncc) and 4 mm on the left coronary cusp (lcc), however it was advised to recapture and place slightly deeper due to the existing plan to perform a post-implant balloon aortic valvuloplasty (bav) to fracture the sav.It was ultimately decided to implant the valve at the current position.Following the successful implant, the post-implant bav was performed with a 23 mm non-medtronic balloon, however the valve ultimately dislodged into the aortic root.Subsequently, a non-medtronic valve was implanted.Per the physician, the depth of implant contributed to the dislodgement.
Additional Manufacturer Narrative
Continuation of d10: product id {d-evolutfx-2329}; product lot/serial number {unknown}; product type: {0195-heartvalves}; implant date {non-implantable} 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 PLUS VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50119308
• Report Number: 9617601-2026-04889
• Device Sequence Number: 18743044
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)280304(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 09/08/2026

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: EVFXPLUS-26
• Device Catalogue Number: EVFXPLUS-26
• 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: 07/31/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/05/2026
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 223 LB