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 Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during partial deployment of this 29 millimeter (mm) transcatheter bioprosthetic valve, the valve dislodged ventricular.The valve was recaptured and repositioned twice.On the third attempt to deploy, the valve was too deep.The valve was attempted to be recaptured however the actuator separated into four pieces.The capsule was closed one-third prior to actuator separation.The valve was recaptured by manually manipulating the delivery catheter system (dcs).It was noted that both deployment knob tabs broke off during the third recapture.The valve and dcs were removed without injury.A 26 mm valve was implanted successfully.No unusual tension was experienced during recapture.It was reported that the dcs was not over-driven.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa 643143, addressing mdr reporting guidance from the fda¿s 1995 preamble, which ensures complaints related to corrections and recalls previously reported to the fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Product analysis: upon receipt of the suspect complaint device at medtronic¿s quality laboratory, visual analysis showed the handle components detached from the dcs.The device was received with the capsule partially opened.The trigger moves to fully advance and retracted positions and locks in place when released.The tip-retrieval mechanism appears intact.The device was returned with the end cap/screw gear snap fit connected.Delamination is observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.The inner member shaft and spindle hub appears intact with no evidence of damage.The tabs are observed to be detached from the male deployment knob component.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 dislodgement and positioning include patient anatomy or physician technique.The dcs was returned to medtronic for analysis.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.The actuator was observed to be detached from the dcs, and the two tabs of the actuator was observed to detached.The two actuator components and the two tabs are mostly likely the "four pieces" reported in the event.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.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: 22443303
• Report Number: 2025587-2025-04844
• Device Sequence Number: 18146983
• Product Code: NPT
• UDI-Device Identifier: 00643169987203
• UDI-Public: (01)00643169987203(17)200418(10)0009091963
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: 04/18/2020
• Device Model Number: ENVPRO-14-US
• Device Catalogue Number: ENVPRO-14-US
• Device Lot Number: 0009091963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2025587-05-28-2021-001-R
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 91 KG