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	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure involving the implant of a transcatheter bioprosthetic aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed using an 18mm balloon.The valve was successfully deployed followed by a post-implant bav using a 20 mm balloon.Digital subtraction angiography and ultrasound were performed and revealed moderate paravalvular leak along with an upward movement of the valve.Subsequently, a second valve was implanted due to the dislodgement of the first valve.
Additional Manufacturer Narrative
Continuation of d10: product id {envpro-16}; product lot number {0012635376}; product type: {0195-heart valves}; implant date: non-implantable device image review: one static image was provided for review.The image provided shows evidence of two valves, evolut in evolut.As stated in the instructions for use, the safety and effectiveness of a corevalve¿ evolut¿ pro bioprosthesis implanted within a failed preexisting transcatheter bioprosthesis have not been demonstrated.The patient¿s executive summary was not provided for anatomical review.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.
Additional Manufacturer Narrative
Conclusion: the device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, and compliance of the aorta and native vessels.Paravalvular leak (pvl) is a known potential adverse effect per the device ifu and can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.In this case, the dislodged valve is likely a contributing factor.Updated: 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.
Additional Manufacturer Narrative
Updated data: d4 h2 h3 image review: the image provided shows evidence of two valves, evolut in evolut; however, the dislodgment event was not captured therefore it is not possible to validate the cause of the dislodgement.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 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: 22205803
• Report Number: 2025587-2025-04237
• Device Sequence Number: 6755880
• Product Code: NPT
• UDI-Device Identifier: 00763000017811
• UDI-Public: (01)00763000017811(17)260320(21)J242598
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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 Expiration Date: 03/20/2026
• 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: 06/07/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 09/02/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female