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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id {d-evprop-2329}; 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 prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty was performed with a 20 millimeter (mm) balloon.Two initial deployment attempts were made, however the valve would not fully expand.The system was subsequently withdrawn from the patient.Following withdrawal, it was observed that the delivery catheter system (dcs) had kinked.A new valve and dcs were opened, an additional pre-implant bav was performed with a 22 mm balloon and the new valve was successfully implanted.Per the physician, the patient's severely calcified anatomy contributed to the expansion issue.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty was performed with a 20 millimeter (mm) balloon.Two initial deployment attempts were made, however the valve would not fully expand.The system was subsequently withdrawn from the patient.Following withdrawal, it was observed that the delivery catheter system (dcs) had kinked.A new valve and dcs were opened, an additional pre-implant bav was performed with a 22 mm balloon and the new valve wassuccessfully implanted.Per the physician, the patient's severely calcified anatomy contributed to the expansion issue.No patient complications were reported as a result of this event.Additional information was received that the valve was recaptured twice due to both frame under expansion and positioning difficulties; however, the under expanded valve was implanted in the patient.Additional information was received to clarify the under expanded valve was used with a new dcs and implanted.Therefore, a second valve was never used.
Additional Manufacturer Narrative
Updated data: b5.D6a.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 prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty was performed with a 20 millimeter (mm) balloon.Two initial deployment attempts were made, however the valve would not fully expand.The system was subsequently withdrawn from the patient.Following withdrawal, it was observed that the delivery catheter system (dcs) had kinked.A new valve and dcs were opened, an additional pre-implant bav was performed with a 22 mm balloon and the new valve wassuccessfully implanted.Per the physician, the patient's severely calcified anatomy contributed to the expansion issue.No patient complications were reported as a result of this event.Additional information was received that the valve was recaptured twice due to both frame under expansion and positioning difficulties; however, the under expanded valve was implanted in the patient.
Additional Manufacturer Narrative
Updated data: b5.D1.D4.H4.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: 24484850
• Report Number: 9617601-2026-01524
• Device Sequence Number: 12012795
• 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,Followup
• Report Date (Section B): 03/10/2026

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-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: 03/06/2026; 03/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/10/2026
• 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 Age: 82 YR
• Patient Sex: Male