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

Model Number	ENVPRO-16-US
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2019
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 delivery catheter system (dcs) at medtronic's quality laboratory, the device was received with the handle components and carriage components detached from the dcs and the end cap/screw gear snap fit connected.Visual analysis showed the tip-retrieval mechanism appeared intact.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.Two kinks were observed on the inner member near the spindle hub.The trigger component was broken.Both tab 3 and tab 4 were detached from the actuator components.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.Recapturing is a feature of the suspect device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including the patient anatomy or physician technique.In this case, anatomical tortuosity was reported which indicates the probable cause of the positioning difficulties was patient anatomy.Positioning difficulties do not typically indicate a device manufacturing issue.Positioning difficulty trends were reviewed and no further action was recommended at this time.It was reported during recapture, the deployment knob of the dcs split in half and the trigger broke.The device was returned for analysis with the handle components and carriage components detached from the dcs.The trigger component was broken and both tab 3 and tab 4 were detached from the actuator components.Delamination between the capsule outer polymer and the nitinol frame, typically occurs when the capsule is subjected to a bending force.Delamination may occur over the spindle/paddle interface if a valve has been misloaded; however, it may also occur due to tracking/positioning in the patient anatomy.The kinks observed on the inner member near the spindle hub do not indicate this damage occurred during the reported issue.Inner member shaft kinks have historically been seen on device returns when the valve has been removed at the back table after event occurred, or when there was no stylet in place during return transport, as was observed in this case.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.With the actuator separated, excess force on the then unsupported trigger may have caused it to break.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, the valve was attempted to be recaptured after being deployed to approximately 20-30%.The reason for recapture was that the depth was initially deeper than the physician would have wanted.During this initial recapture attempt, the physician reported that the deployment knob of the delivery catheter system (dcs) split in half.The grey slider trigger broke when the knob split.The physician was unable to fully recapture the valve.The medtronic field rep was able to manually maneuver the dcs to fully recapture the valve so that the valve and failed dcs could be removed from the body.Anatomical tortuosity was reported.A second valve was opened and loaded onto a new dcs.The second valve was implanted successfully.It was reported that the physician is a highly experienced implanter.No adverse patient effects were reported.

• 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: 22493813
• Report Number: 9612164-2025-03429
• Device Sequence Number: 18264054
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: (01)00643169987210(17)210221(10)0009608258
• 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): 07/14/2025

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: 02/21/2021
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009608258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• 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: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2019
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 98 KG