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); 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	05/30/2017
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 at medtronic¿s quality laboratory, visual analysis showed the valve was received loaded in the capsule of the suspect complaint delivery catheter system (dcs).The valve did not appear misloaded as both valve paddles were in the spindle pockets.Visual inspection showed the dcs was received with the end cap/screw gear snap fit connected and the tip-retrieval mechanism appeared intact.There was no damage observed to the spindle hub.The deployment knob was separated; the two tabs were detached from the deployment knob.On attempted retraction of the capsule via the rotation of the inner slide assembly, the valve deployed as expected.Additionally, one static fluoroscopic image of the load inspection was submitted to medtronic for review; however, results were deemed inconclusive whether the load was adequate.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.In this event, the valve was recaptured twice, which is typically due to suboptimal positioning of the valve.Recapture is a design feature to allow re-positioning of the valve.Without additional information, an assignable root cause leading to the presumed suboptimal positioning could not be determined.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.The subject dcs was returned and evaluated.The two tabs were detached from the deployment knob, but upon attempted retraction of the capsule via the rotation of the inner slide assembly, the valve deployed as expected.Overall, the device evaluation confirmed the reported actuator separation, but also confirmed the capsule can still be deployed and/or recaptured via the inner assembly and trigger.An actuator separation can prevent loading, deployment, or recapture through normal use, and can be related to procedural, anatomical and/or device factors.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 during the implant of this transcatheter bioprosthetic valve, during the second recapture of the valve, the delivery handle separated and could not be recaptured any further.The valve was pulled to the ascending aorta and the handle still was not able to recapture the valve.The handle was pushed together and the valve was able to be recaptured and removed from the patient.The valve and delivery catheter system (dcs) will be returned to medtronic and a new valve was loaded onto a new dcs.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: 22340618
• Report Number: 2025587-2025-04570
• Device Sequence Number: 15718433
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: 00643169956193
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/26/2025

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: 02/16/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008499351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• 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: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2017
• 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 Age: 79 YR
• Patient Sex: Male