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); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id d-evolutfx-2329 (lot: 0013352755); 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.
Event or Problem Description
It was reported that during a transcatheter aortic valve implant procedure, after deployment of the valve, an infold was noted.Subs equently, a 23-millimeter (mm) non-medtronic balloon was prepped for a post-implant balloon aortic valvuloplasty (bav).The balloon was then placed at the 29 mm valve, and as the post-implant bav was being completed, rapid pacing was reduced from 180 beats per minute (bpm) to 120 bpm at request of the attending physician.As the rapid pacing was decreased, the balloon was not fully inflated, causing the valve to embolize into the descending aorta.Subsequently, a new 29 mm valve was prepared and successfully implanted.A 1-hour procedural delay occurred due to the valve infold and dislodge.Per the physician, the early termination of the rapid pacing and late inflation of the post-implant bav contributed to the valve dislodge.Additionally, the physician reported that the procedure contributed to the valve infold and dislodge.

• 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: 25331158
• Report Number: 9617601-2026-03476
• Device Sequence Number: 21297381
• Product Code: NPT
• UDI-Device Identifier: 00763000716141
• UDI-Public: (01)00763000716141(17)280214(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/25/2026

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-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: 05/27/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 02/14/2026
• 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...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 99 KG