MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTPRO-23-US
Medical Device Problem Codes	Material Invagination (1336); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: this is a system report.The section d information is for the primary device, which was in use with the following: enveo pro delivery catheter system (dcs), product id: envpro-16-us, serial/lot #: (b)(6), ubd: 01-jul-2026, udi#: (b)(4).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 involving a 23 mm evolut pro system, a pre-implant balloon dilation was performed with an 18 mm balloon.According to the reporter, due to calcification, the 23 mm valve was recaptured and infolded.Then, on the subsequent deployment of the valve, the frame was still infolded, and the right sinus on the greater curvature was "damaged." no clinical symptoms or interventional actions were recounted for this vessel damage.The 23 mm valve system was withdrawn and discarded, and a 26 mm valve system was successfully used for implant.
Additional Manufacturer Narrative
Additional information received showed there was no information to reasonably suggest the dcs in this report caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this device previously listed as a system reported product does not meet the reporting requirements in 21 cfr 803.Updated data: b5.A second paragraph was added.D10.Let this report reflect there were concomitant devices in use during the event; however, there is no system reported device.Medtronic device: enveo pro delivery catheter system (dcs), product id: envpro-16-us, lot #: 0012338854, ubd: 01-jul-2026, udi#: (b)(4).This is a non-implantable device.H6.Let this report reflect the patient code shows no vascular injury occurred to the patient.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 involving a 23 mm evolut pro system, a pre-implant balloon dilation was performed with an 18 mm balloon.According to the reporter, due to calcification, the 23 mm valve was recaptured and infolded.Then, on the subsequent deployment of the valve, the frame was still infolded, and the right sinus on the greater curvature was "damaged." no clinical symptoms or interventional actions were recounted for this vessel damage.The 23 mm valve system was withdrawn and discarded, and a 26 mm valve system was successfully used for implant.Additional information was received to report the infold occurred after the first recapture.Per the physician, the patient's native annulus had "lumpy" calcification which contributed to the infold.It was clarified no vascular damage occurred; it was noted a subsequent ultrasound may have revealed calcification/vegetation on the native valve leaflet.A procedural delay did not occur as a result of changing to a new system.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21646807
• Report Number: 2025587-2025-01989
• Device Sequence Number: 18030796
• Product Code: NPT
• UDI-Device Identifier: 00763000017811
• UDI-Public: 00763000017811
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Expiration Date: 11/26/2025
• Device Model Number: EVOLUTPRO-23-US
• Device Catalogue Number: EVOLUTPRO-23-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: 03/15/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sex: Female