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); Malposition of Device (2616)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id d-evprop2329us (lot: 0013200093); product type: 0195-heart valves; implant date ; explant date 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 valve was implanted but was noted to be positioned r elatively high in relation to the aortic annulus.Additionally, it was noted that there was significant paravalvular leak.In response, the attending physician decided to implant a second valve into the previously implanted valve.After implantation of the second transcatheter valve, moderate paravalvular leak was still identified.Subsequently, it was decided to implant a non-medtronic (abbott) vascular plug to combat the paravalvular leak.
Additional Manufacturer Narrative
This is a system report.The section d.Information is for the primary device, which was in use with the following device(s) which cannot be excluded as potential contributing factors to the adverse event: medtronic brand name: evolut pro plus dcs; product id: d-evprop2329us; lot: 0013200093; udi: (b)(4); manufactured date: 2025-12-19; use by date: 2027-12-19; implant date: not-implantable; fda site id: 9612164.Image review: a pre-implant patient executive summary was not provided; therefore, a comprehensive pre-procedural anatomical assessment could not be completed.One intraprocedural fluoroscopic cine was submitted for review.Review of the available imaging demonstrates the presence of two evolut transcatheter heart valves (evolut-in-evolut configuration) and a paravalvular leak plug, with a possible trace paravalvular leak.As no additional imaging was provided, a comprehensive analysis could not be completed.Updated data: b5.H6.H11.System reported device added 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.
Event or Problem Description
Additional information was received that the first valve was inadvertently deployed at an unintended depth.Following the implant of the vascular plug, mild pvl remained.
Additional Manufacturer Narrative
Updated data: b5.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 valve was implanted but was noted to be positioned r elatively high in relation to the aortic annulus.Additionally, it was noted that there was significant paravalvular leak (pvl).In response, the attending physician decided to implant a second valve into the previously implanted valve.After implantation of the second transcatheter valve, moderate paravalvular leak was still identified.Subsequently, it was decided to implant a non-medtronic vascular plug to combat the paravalvular leak.Additional information was received that the first valve was inadvertently deployed at an unintended depth.Following the implant of the vascular plug, mild pvl remained.Additional information was received that the intended implant depth of the first valve was 3 millimeters (mm).The actual implant depth of the first valve was 0 mm.

• 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: 24916728
• Report Number: 9617601-2026-02534
• Device Sequence Number: 13217534
• Product Code: NPT
• UDI-Device Identifier: 00763000211110
• UDI-Public: (01)00763000211110(17)280108
• 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
• Report Date (Section B): 04/28/2026

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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/18/2026; 04/26/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/23/2026; 04/28/2026
• Date Device Manufactured: 01/08/2026
• 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 Sex: Male