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

Model Number	EVOLUTPRO-23-US
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id envpro-16-us (lot: 0012997828); product type: 0195-heart valves; implant date (b)(6) 2026; explant date (b)(6) 2026 select patient information cannot be included in the regulatory report due to regional privacy regulations.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, the delivery catheter system (dcs) was inserted into the patient and advanced to the aortic annulus.Upon first deployment to the working position, it was noted that the valve frame was severely compressed.Subsequently, the valve was recaptured and withdrawn from the patient to allow for the guidewire direction to be adjusted.The dcs was reinserted into the patient and then advanced through the patient's anatomy.However, the dcs was unable to advance past the aortic valve because the "marker" direction was incorrect.Subsequently, the dcs was again withdrawn from the patient and a new dcs was utilized to complete the procedure.No patient complications were reported as a result of this event.
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.Upon first deployment to the working position, it was noted that the valve frame was severely compressed.Subsequently, the valve was recaptured and withdrawn from the patient to allow for the guidewire direction to be adjusted.The dcs was reinserted into the patient and then advanced through the patient's anatomy.However, the dcs was unable to advance past the aortic valve because the "marker" direction was incorrect.Subsequently, the dcs was again withdrawn from the patient and a new dcs was utilized to complete the procedure.No patient complications were reported as a result of this event.Additional information to clarify that the "marker" is referring to the hat marker and its incorrect orientation.The operator suspected there was an issue with the dcs tip; therefore, a new dcs was used to reload the same valve to complete the procedure.
Additional Manufacturer Narrative
Updated data: b5.D4.D6a.H4.H6.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 PRO TRANSCATHETER AORTIC 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: 25021572
• Report Number: 9617601-2026-02802
• Device Sequence Number: 18549789
• Product Code: NPT
• UDI-Device Identifier: 00763000017811
• UDI-Public: (01)00763000017811(17)270919
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2026

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: EVOLUTPRO-23-US
• Device Catalogue Number: EVOLUTPRO-23-US
• 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: 04/26/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/06/2026; 05/06/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/06/2026; 05/07/2026
• Date Device Manufactured: 11/18/2025
• 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 Age: 71 YR
• Patient Sex: Female