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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) deployment knob separated completely during deployment while the valve was opened to 20%.The deployment knob was put back together enough to recapture the valve and the system was removed.The valve was stuck in the dcs due to the separation.No abnormal tension was reported in the system.The valve and dcs were not used and a new valve and dcs were successfully used for implant.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 tip-retrieval mechanism appears intact.The trigger moves to fully advance and retracted positions and locks in place when released.The device was returned with the end cap/screw gear snap fit connected.The device was received with the capsule partially opened.Delamination is observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.The spindle hub appears intact with no evidence of damage.Two kinks are observed along the inner member shaft.The flush port is deformed.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.The subject dcs was returned for analysis.The device was received with the handle components detached from the dcs.The tabs are observed to be detached from the male deployment knob component.Thus, confirming the reported event.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.Delamination between the capsule outer polymer and the nitinol frame, typically occur when the capsule is subjected to a bending force.A void may occur over the spindle/paddle interface if a valve has been misloaded; however, voids may also occur due to tracking/positioning in the patient anatomy.Two kinks were observed along the inner member shaft and the flush port was noted to be deformed.The description of the event does not indicate that this damage occurred during the reported issue.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: 22467299
• Report Number: 2025587-2025-04884
• Device Sequence Number: 7940893
• Product Code: NPT
• UDI-Device Identifier: 00643169987203
• UDI-Public: (01)00643169987203(17)201016(10)0009384772
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/10/2025

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: 10/16/2020
• Device Model Number: ENVPRO-14-US
• Device Catalogue Number: ENVPRO-14-US
• Device Lot Number: 0009384772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• 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: 07/10/2025
• Date Device Manufactured: 10/17/2018
• 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: 68 YR
• Patient Sex: Male