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 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	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant of a transcatheter valve, there was poor visualization in the non-coronary sinus due to the patient's low calcification, and the valve was implanted too high.Following the implant, the valve dislodged into the sinus.Subsequently, the valve was pulled into the ascending aorta and a second valve was implanted; however, the first valve pushed the second valve down to a deeper position.Therefore, third valve was implanted valve-in-valve to "seal" the paravalvular leak (pvl).Following the implant of the third valve, a small amount of pvl was observed, and the patient's blood pressure was 96/65 millimeters of mercury (mm hg).
Additional Manufacturer Narrative
Select patient information cannot be included in regulatory report due to regional privacy regulations.Continuation of d10: product id: envpro-16-us (unknown); product type: 0195-heart valves; implant date: n/a; explant date: n/a.Product id: evolutpro-23 (serial: (b)(6); product type: 0195-heart valves; implant date: on (b)(6) 2025.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.
Additional Manufacturer Narrative
Image review: three fluoroscopic media files were provided for review.Fluoroscopic valve load inspection was not provided for review thus a good load cannot be validated.A pre-implant balloon dilation was performed prior to the valve implantation.It was reported that the first valve dislodged to the level of the sinus of valsalva; however, the image provided shows a left ventriculogram and valve position cannot be validated.The media files show evidence of at least two valves, one in the ascending aorta and second valve being implanted in the aortic annulus and signs of possible mild-moderate aortic regurgitation/paravalvular leak (pvl).It was reported that a third valve was implanted valve-in-valve to seal the leak, but images of the third valve implantation were not made available.As stated in the instructions for use (ifu): potential risks associated with the implantation of the bioprosthesis may include, but are not limited to, the following: prosthetic valve migration/embolization.The patient¿s executive summary was not provided for anatomical review.Updated: b2, b5, 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.
Event or Problem Description
It was reported that during the implant of a transcatheter valve, there was poor visualization in the non-coronary sinus due to the patient's low calcification, and the valve was implanted too high.Following the implant, the valve dislodged into the sinus.Subsequently, the valve was pulled into the ascending aorta and a second valve was implanted; however, the first valve pushed the second valve down to a deeper position.Therefore, third valve was implanted valve-in-valve to "seal" the paravalvular leak (pvl).Following the implant of the third valve, a small amount of pvl was observed, and the patient's blood pressure was 96/65 millimeters of mercury (mm hg).Additional information was received that a pre-implant balloon dilation was performed using an 18 mm non-medtronic (z-med) balloon.Prior to implanting the third valve, the pvl was severe.

• 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: 23923292
• Report Number: 9617601-2025-03787
• Device Sequence Number: 13019131
• Product Code: NPT
• UDI-Device Identifier: 00763000017811
• UDI-Public: (01)00763000017811(17)270412
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 06/11/2025
• 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...
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 52 KG