MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION 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	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.Section d references the main component of the system.Other medical products in use during the event include: product id evproplus-34us (serial: (b)(6); product type: 0195-heart valves; implant date n/a; explant date n/a product analysis: upon receipt of the suspect complaint device at medtronic¿s quality laboratory, visual analysis showed the handle appeared intact.The device was received with the nosecone slightly over-captured by the capsule.On retraction of the capsule via the rotation of the deployment knob, the original valve deployed as expected.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.The capsule appeared intact with no evidence of damage.The inner member shaft and spindle hub appeared intact with no evidence of damage.There was damage observed on the threading of the screw gear.A valve was successfully loaded onto the delivery catheter system (dcs).On retraction of the capsule via the rotation of the deployment knob, the valve deployed as expected and the reported event for dislodgement could not be confirmed in the analysis.Conclusion: the dcs was returned to medtronic for analysis with the nosecone slightly over-captured by the capsule.The device instructions for use (ifu) cautions the user to ¿stop advancing the capsule once the gap to the catheter tip is closed.Advancing the capsule farther could damage the capsule¿.There was damage observed on the threading of the screw gear.This damage is consistent with the increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy.There is no information to suggest a failure to meet specifications 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, it was reported that the valve would not stay in position.At 80% deployed, the valve would dislodge up.3 attempts were made to deploy the valve without success.The valve was withdrawn and the procedure was aborted.The valve was not implanted.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: 21953161
• Report Number: 2025587-2025-03333
• Device Sequence Number: 8535101
• Product Code: NPT
• UDI-Device Identifier: 00763000207861
• UDI-Public: 00763000207861
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/02/2025

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: 10/06/2023
• Device Model Number: D-EVPROP34US
• Device Catalogue Number: D-EVPROP34US
• Device Lot Number: 0010883378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 116 KG