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

Model Number	EVPROPLUS-34US
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id {d-evprop-34}; product lot/serial number (b)(6); product type: {0195-heartvalves}; implant date {non-implantable} 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 valve, the valve infolded.Per the physician, the patient's anatomy contributed to the infold.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Updated data: 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.
Event or Problem Description
It was reported that during the attempted implant of a transcatheter aortic valve, the valve infolded.Per the physician, the patient's anatomy contributed to the infold.No patient complications were reported as a result of this event.Additional information was received that there was no misload identified during loading.The infold of the valve frame was first noticed during the first recapture.The valve was recaptured one time due to the implant depth being too deep.Subsequently, the valve was not implanted and was withdrawn from the patient.Per the physician, the patient's anatomy, specifically annular calcification, contributed to the infold.It was noted that a procedural delay occurred as a result of the infold.
Additional Manufacturer Narrative
Image review: one fluoroscopic media file was available for review and demonstrated infolding of the evolut frame.Fluoroscopic valve load inspection images were not available for review; therefore, confirmation of appropriate valve loading could not be assessed.However, a misload was not reported, and the documentation indicated that the infolding was observed after the first recapture, which most likely contributed to the infolding observed.The infold is characterized by an inward fold or crease in the valve, extending from the inflow.Infolding could¿occur due to a misloaded valve, anatomical characteristics such as calcium, and recaptures.If an infold is identified, the valve should be recaptured and removed from the body.New sterile components must be used.It was reported that the infolded valve was recaptured and withdrawn from the patient.A pre-implant patient executive summary was not provided; therefore, a comprehensive pre-procedural anatomical assessment could not be performed.Available documentation indicates that annular calcification was present.Updated data: 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.

• 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: 25045776
• Report Number: 9617601-2026-02834
• Device Sequence Number: 9921285
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: (01)00763000211158(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
• 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
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 05/12/2026; 05/14/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/12/2026; 06/09/2026
• 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...
• Patient Sex: Male