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); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the implant of a 29 millimeter (mm) transcatheter aortic valve, the valve dislodged.Subsequently, the valve was snared into the sinotubular junction (stj), and a 34 mm valve was implanted valve-in-valve.An additional valve was implanted in the ascending aortic arch in order to secure the 34 mm valve.
Additional Manufacturer Narrative
Continuation of d10: product id {envpro-16}; product lot/serial number {(b)(6)}; product type: {0195-heartvalves}; implant date {non-implantable} product id {evproplus-34}; product lot/serial number {(b)(6)}; product type: {0195-heartvalves}; implant date: {(b)(6) 2026}, explant date: {n/a} 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.
Additional Manufacturer Narrative
Image review: five intraprocedural fluoroscopic media files were submitted for review.Fluoroscopic valve load inspection images were not provided; therefore, confirmation of appropriate valve loading could not be performed.Based on the available evidence, the valve was observed to be displaced above the aortic annulus during the procedure and was subsequently snared above the sinotubular junction (image 1).The dislodgement event was not captured in the submitted media; therefore, the cause of the valve dislodgement could not be determined.Review of the available fluoroscopic images suggests that difficulty was encountered during advancement of the second delivery catheter system (dcs) (image 2).The dcs was ultimately advanced, and a second valve was implanted at an estimated depth of 0 mm at the non-coronary cusp (ncc) (image 3).Additional evidence indicates that a third valve was deployed above the dislodged valve (image 4).Updated: 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
Additional information was received that a pre-implant balloon dilation was not performed.A non-medtronic guidewire was used for the procedure.The patient's anatomy had mild calcification and a large annulus, making anchoring difficult.The first valve deployment starting point was at the bottom of the pigtail catheter.Prior to dislodgement, the depth was approximately 0 mm on the non-coronary cusp (ncc).After dislodgement, the depth on the ncc was at least 20 mm with significant perivalvular leak and a persistent decrease in blood pressure.Subsequently, a third valve was implanted, primarily due to the severe dislodgement of the 29 mm valve in the ascending aorta, which was unable to anchor and continuously rotated, posing a high risk of dissection.Therefore, after detailed measurement, a 34 mm valve was implanted as an intra-valvular prosthesis within the 29 mm valve to stabilize the dislodged 29 mm va lve.
Additional Manufacturer Narrative
Updated data: b2.B5.H6.Additional codes.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
Updated data: h6, h6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.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: 24714602
• Report Number: 9617601-2026-02083
• Device Sequence Number: 6087708
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2026

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: 03/26/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 03/31/2026; 05/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/02/2026; 05/13/2026
• 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: Male