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

Model Number	ENVEOR-N-US
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to the implant of a 29mm transcatheter bioprosthetic valve, was loaded on the delivery catheter system¿s (dcs).A fluoroscopy check confirmed a good load.The valve was then deployed too deep and was recaptured.During redeployment of the valve, the blue deployment knob separated into two pieces and fell apart from the dcs.The operator had to manually assemble the deployment knob and mount it back on the dcs.The deployment was completed successfully, and 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 delivery catheter system (dcs) at medtronic¿s quality laboratory, the device was received with the capsule fully closed without the stylet in place.The inner member and spindle hub appeared intact with no evidence of damage.The device was returned with the end cap/screw gear snap fit connected.Visual analysis showed the device was received with the handle components detached from the dcs.The two tabs were detached from the male deployment knob.The detachment site of the two tabs were observed to be smooth.The tip-retrieval mechanism appeared intact.The distal edge of the capsule seats flush against the catheter tip when fully advanced.A small void was observed over the nitinol reinforcing frame along the proximal end of the capsule.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.A device history record (dhr) review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The reported event indicates that the valve was recaptured due to sub-optimal positioning during the initial deployment attempt.Rec apturing is a feature of the device to allow for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications; the cause cannot be determined.It was reported the deployment knob (actuator) separated during the second deployment attempt.The suspect dcs was returned for analysis which confirmed the reported actuator separation.The tabs were detached from the actuator components.Voids were observed on the capsule, which indicate delamination between the capsule outer polymer and the nitinol frame and typically occur when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy, or if a valve was misloaded.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 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: 22359678
• Report Number: 2025587-2025-04626
• Device Sequence Number: 12916863
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: (01)00643169956193(17)190718(10)0008719532
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/30/2025

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: 07/18/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008719532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• 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: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2017
• 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: Male