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

Model Number	EVPROPLUS-26US
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Valvular Insufficiency/ Regurgitation (4449); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: d-evprop-2329; product lot/serial number: (b)(6); product type: 0195-heartvalves.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 the attempted implant of a transcatheter aortic bioprosthetic valve (tav), upon the first deployment attempt, circulatory collapse and a drop in blood pressure was observed.Subsequently, the valve was recaptured to adjust the deployment depth.The valve was successfully implanted on the second attempt, however the patient's blood pressure did not recover.Cardiopulmonary resuscitation (cpr) was performed and extracorporeal membrane oxygenation (ecmo) was initiated.Subsequently, upon image review it was observed that the valve had migrated, with "significant" paravalvular leak (pvl).A second valve was implanted in a deeper position, and a post-implant balloon aortic valvuloplasty (bav) was performed with a 22 millimeter (mm) balloon, which provided significant improvement to the pvl.
Additional Manufacturer Narrative
This report was identified as a duplicate.Please reference regulatory report number 9617601-2026-01591 for information pertaining to this event.Additional information received shows that there is no information to reasonably suggest that the valve in this report may have caused or contributed to a death or serious injury or that the valve in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Updated data: 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT PRO 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: 24484912
• Report Number: 9612164-2026-01080
• Device Sequence Number: 20106787
• Product Code: NPT
• UDI-Device Identifier: 00763000211110
• UDI-Public: (01)00763000211110(17)270619
• 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
• Report Date (Section B): 03/04/2026

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: EVPROPLUS-26US
• Device Catalogue Number: EVPROPLUS-26US
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 06/19/2025
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 43 KG