MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	ENVPRO-14-US
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, at 80% deployment after making annular contact and before getting through the ¿rumble strips,¿ the valve dislodged above the annulus and into the ascendingaorta by the cardiac output.It was reported that the operator did not have control of the non-medtronic wire and the wire also dislodged up into the ascending aorta.The system was removed and the wire was advanced to successfully re-cross the valve.An 18 fr non-medtronic sheath was used in the right common femoral artery throughout the procedure.A new valve was loaded as the first valve had been in the body and partially deployed.The valve was successfully implanted.No adverse patient effects were reported.
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 evolutr-23-us (serial: (b)(6)); product type: 0195-heart valves; implant date n/a; explant date n/a product analysis: the suspect complaint product was received at medtronic¿s quality laboratory; visual analysis showed the handle ap peared intact.Delamination was observed over the nitinol reinforcing frame along the proximal end to mid-section of the capsule.The device was received with the capsule over captured.The capsule could not be successfully retracted using either the deployment knob, or by using the trigger.On attempt of retraction of the capsule via the rotation of the deployment knob the capsule bent.The device was returned with the end cap/screw gear snap fit connected.The device was sent for fluoroscopy to determine the condition of the valve, and it was confirmed that the valve was damaged within the capsule.The reported event for dislodged valve could not be confirmed in the analysis.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.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¿.The capsule could not be successfully retracted using either the deployment knob, or by using the trigger.On attempt of retraction of the capsule via the rotation of the deployment knob the capsule bent.Fluoroscopy was performed on the capsule to determine the condition of the valve and it was confirmed that the valve was damaged in the capsule.It is possible that the valve was damaged when recapturing the valve following the reported dislodgement.It was not possible to deploy the valve and the attempts to deploy the valve most likely resulted in the capsule bending.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.Dislodgement events do not typically indicate a failure to meet manufacturing specifications.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: ENVEO PRO DELIVERY SYSTEM
• 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: 21263927
• Report Number: 2025587-2025-00752
• Device Sequence Number: 15805871
• Product Code: NPT
• UDI-Device Identifier: 00643169987203
• UDI-Public: 00643169987203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/29/2025

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: 03/01/2023
• Device Model Number: ENVPRO-14-US
• Device Catalogue Number: ENVPRO-14-US
• Device Lot Number: 0010583872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: 73 YR
• Patient Sex: Male