MAUDE Adverse Event Report: MEDTRONIC IRELAND EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVPROP34US
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: concomitant medical devices in use during the event include: product id: {evproplus-34us}; product serial/lot number: {(b)(6)}; product type: {0195-heart valves}; implant date: {n/a}; explant date: {n/a}.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 valve, the valve was deployed up to two-thirds; however, a "kink" was observed on the valve stent frame.Subsequently, the valve was withdrawn from the patient, and a new valve and new delivery catheter system (dcs) were used to complete the procedure.No patient complications were reported as a result of this event.Additional information was received that an infold did not occur.The valve was recaptured and redeployed 3 times due to the valve dislodging, and at two-thirds deployment, the valve frame appeared bent.Per the physician, the patient's calcified fused spine contributed to the event.It was noted that a procedural delay occurred in result of the bent frame.
Additional Manufacturer Narrative
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 22 mm pre-implant dilatation was performed after the first valve was withdrawn from the patient.
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
Additional information was received that prior to the valve implant, a pre-implant balloon dilation was performed with a 20 millimeter (mm) balloon.It was reported that a re-dilatation was performed with a 22 mm balloon.

• Brand Name: EVOLUT PRO PLUS DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24345626
• Report Number: 9612164-2026-00833
• Device Sequence Number: 9673990
• Product Code: NPT
• UDI-Device Identifier: 00763000207861
• UDI-Public: (01)00763000207861(17)261009(10)0012480385
• 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): 03/06/2026

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: D-EVPROP34US
• Device Catalogue Number: D-EVPROP34US
• Device Lot Number: 0012480385
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 03/05/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/06/2026
• Date Device Manufactured: 10/09/2024
• 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: Male