MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-34
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that prior to the implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to calcification.Upon fluoroscopic inspection of the valve load, an infold was not definitively confirmed.Upon the first deployment attempt, an infold was identified.Following the implant of the valve and after removing the delivery catheter system (dcs), a transesophageal echocardiogram (tee) was performed that confirmed the infold in the valve frame subsequently, a post-implant balloon aortic valvuloplasty was performed with a 24 millimeter (mm) balloon to resolve the infold.It was later identified that frame node overlap to the 4th node occurred during loading of this valve, constituting a misload that was not identified and the misloaded valve and dcs were used for implantation.It was noted that the misload was not due to a new valve loader.No patient complications were reported as a result of this event.

• 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: 25174417
• Report Number: 9617601-2026-03131
• Device Sequence Number: 10567272
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• UDI-Public: (01)00763000716158(17)271031(20)01
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/17/2026

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-34
• Device Catalogue Number: EVFXPLUS-34
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 10/31/2025
• 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 Sex: Male
• Patient Weight: 62 KG