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

Model Number	EVFXPLUS-29
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, following the implant of the transcatheter aortic valve, paravalvular leak (pvl) of unknown severity occurred.A post-implant balloon aortic valvuloplasty (bav) was performed while the patient was rapidly paced.Subsequently, the valve dislodged.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) and left coronary cusp (lcc) was 4 millimeter's (mm).After valve dislodgement, the implant depth on the ncc and lcc was -2 mm.The original valve was left in the sinus, and a second valve was implanted valve-in-valve at an implant depth of 6 mm.It was noted that mild pvl was observed post deployment, but a post-implant bav was not performed.Per the physician, the cause of the dislodgement was due to the post-implant bav and the depth of implant.
Additional Manufacturer Narrative
D10.Continuation - concomitant medical devices in use during the event include: medtronic product id: d-evolutfx-2329; product serial/lot number: (b)(6); product type: 0195-heart valves; implant date: not-imp lantable; explant date: na.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: 50060132
• Report Number: 9617601-2026-04667
• Device Sequence Number: 13098824
• Product Code: NPT
• UDI-Device Identifier: 00763000716141
• UDI-Public: (01)00763000716141(17)280309(20)01
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Report Date (Section B): 07/28/2026

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: EVFXPLUS-29
• Device Catalogue Number: EVFXPLUS-29
• 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: 07/23/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 03/10/2026
• 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: 65 YR
• Patient Sex: Female