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-29-US
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a transcatheter aortic valve implant procedure, after implantation of the valve, mild paravalvular leak (pvl) was noted.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was completed with a 23-millimeter (mm) balloon.During the post-implant bav, the valve dislodged, which resulted in the patient having severe pvl.In response, the attending physician decided to implant a second valve into the previously implanted valve.After implant of the second transcatheter valve, the patient's pvl improved.
Additional Manufacturer Narrative
Continuation of d10: product id envpro-16-us (lot: 0012896875); 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Updated data: b5.Corrected data: h6.Annex e code was erroneously omitted from the initial medwatch.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 implantation of the valve, mild paravalvular leak (pvl) was noted.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was completed with a 23-millimeter (mm) balloon.During the post-implant bav, the valve dislodged, which resulted in the patient having severe pvl.In response, the attending physician decided to implant a second valve into the previously implanted valve.After implant of the second transcatheter valve, the patient's pvl improved.Additional information was received that a pre-implant bav was not performed as the patient's calcification was not considered severe.A pre-shaped guidewire was used during the implant procedure.The deployment starting point was at the mid-section of the pigtail catheter.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) and the left coronary cusp (lcc) was 3 mm.The direction of dislodgement was aortic.After valve dislodgement, the implant depth on the ncc and lcc was 0mm.Following the implant of the second valve, mild pvl remained.There was nothing in terms of patient anatomy that contributed to the dislodge.

• 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: 24915695
• Report Number: 9617601-2026-02531
• Device Sequence Number: 13078756
• Product Code: NPT
• UDI-Device Identifier: 00763000017835
• UDI-Public: (01)00763000017835(17)270404
• 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
• Report Date (Section B): 04/21/2026

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-29-US
• Device Catalogue Number: EVOLUTPRO-29-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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 06/03/2025
• 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: 78 YR
• Patient Sex: Female