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	Material Invagination (1336); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
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 aortic annulus.The valve was then deployed but subsequently recaptured due to sub-optimal positioning and valve under expansion.The valve was then repositioned in that it was 4-millimeters (mm) from the non-coronary cusp (ncc) and 5 mm from the left coronary cusp (lcc).The valve was then deployed for a second time, however, during the second deployment attempt an infold was noted.Subsequently, the valve was recaptured and removed from the patient's body.A balloon aortic valvuloplasty was then completed with a non-medtronic balloon.A new dcs was then utilized to successfully implant a new valve.Per the physician, the patient's calcified anatomy contributed to the event.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id d-evolutfx-2329 (lot: 0012997821); product type: 0195-heart valves; 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 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 ; 091708096
• MDR Report Key: 25205591
• Report Number: 9617601-2026-03202
• Device Sequence Number: 18650928
• Product Code: NPT
• UDI-Device Identifier: 00763000716141
• UDI-Public: (01)00763000716141(17)280221(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/18/2026

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: 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: 05/14/2026
• Initial Report FDA Received Date: 05/18/2026
• Date Device Manufactured: 02/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 104 KG