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

Model Number	ENVEOR-US
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
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 with the capsule fully closed, visual analysis showed the deployment knob has separated from the handle of the dcs and was returned loose.A tab is damaged and hinged back on one of the loose deployment knob components.A stress mark is observed on the deployment knob components opposite tab.Despite the deployment knob components being detached from the device, the capsule could be retracted by retracting the t-core.The device was returned with the end cap/screw gear snap fit connected.The distal edge of the capsule seats flush against the catheter tip when fully advanced.The capsule appears intact with no evidence of damage.The inner member shaft appears intact with no evidence of damage.Conclusion: actuator separation is typically associated broken or damaged snap fit tabs, either one tab or both, which hold the handle together.An actuator separation will prevent loading and/or deployment through normal use.Analysis of the returned dcs confirmed the reported actuator separation, but there were no findings to suggest a device quality deficiency related to the manufacturing of the device.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 prior to the implant of this transcatheter bioprosthetic valve, while loading the 29mm valve into the appropriate size compression loading system (cls), the blue deployment knob of the delivery catheter system (dcs) separated due to what appeared to be excessive force.It was reported that the separation occurred while the deployment knob was being turned and that no unusual resistance was felt while loading.The deployment knob was assembled back together to allow the tech to remove the valve from the capsule.The valve was removed from the capsule and was placed in warm sterile water.The valve was reloaded into a new delivery catheter and was successfully deployed.No adverse patient effects were reported.

• Brand Name: ENVEO R 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: 22323176
• Report Number: 2025587-2025-04485
• Device Sequence Number: 8924518
• Product Code: NPT
• UDI-Device Identifier: 00643169633353
• UDI-Public: 00643169633353
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/24/2025

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: 09/19/2017
• Device Model Number: ENVEOR-US
• Device Catalogue Number: ENVEOR-US
• Device Lot Number: 0008224354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• 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: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2016
• 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 Sex: Unknown