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

Model Number	D-EVPROP2329US
Medical Device Problem Codes	Structural Problem (2506); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.This is a system report.The section d information is for the primary device, which was in use with the following: product id: evproplus-26us, (b)(6), ubd: (b)(6) 2023, (b)(4) image review: the images and pictures received are not enough to review for the event reported.The mechanism of the bent inflow strut is not clear and with no video of the fluoroscopy it cannot be assessed nor any potential cause.Conclusion: the valve 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.Based on the image review, the reported bent strut cannot be confirmed.The procedural images provided did not capture the reported dislodgement.Potential factors that can influence dislodgement include tension applied on the delivery catheter system (dcs) during positioning, calcification levels and shape of the native anatomy.In this case it was reported that the valve dislodged as a result of a premature ventricular contraction (pvc).Dislodgement events do not typically indicate a failure to meet manufacturing specifications.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the instructions for use (ifu) contains instructions to use the integrated loading bath which features a mirror to ensure that all bioprosthesis outflow struts are symmetrical and captured in the capsule during loading and to aid in accurate placement of the valve frame paddles during loading.The ifu instructs to visually and tactilely inspect the capsule for a misloaded bioprosthesis.There is no information to suggest a device quality d eficiency that may have caused or contributed to this event.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
Medtronic received information that during implant of this transcatheter bioprosthetic valve, into a patient with an existing medtronic surgical aortic valve, the transcatheter valve was deployed to 80%, and dislodged as a result of a premature ventricular contraction (pvc).The valve was recaptured in the ascending aorta about the surgical valve.Upon re-deployment, the camera angle was adjusted and reported a bent valve strut, at the inflow of the valve.The team elected to fully release the valve.The valve was post dilated using a 20 millimeter (mm) non-medtronic (true) balloon.The bent strut moved slightly, but did not fully resolve.There was no residual gradient or paravalvular leak (pvl) reported following the implant.The patient remained stable throughout.No adverse patient effects were reported.

• Brand Name: EVOLUT PRO PLUS DCS
• 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: 21979261
• Report Number: 2025587-2025-03502
• Device Sequence Number: 18415790
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 11/10/2023
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010929361
• 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: 02/11/2022
• Initial Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 11/10/2021
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 92 KG