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); Detachment of Device or Device Component (2907); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2018
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, visual analysis showed the handle components detached from the dcs.The device was received with the capsule partially open.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.Delamination is observed over the nitinol reinforcing frame on the proximal end of the capsule.The inner member shaft narrows at the base of the nose cone so the stylet cannot be inserted into the device.The tabs are observed to be detached from the male deployment knob component.The hooks 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.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.The dcs was returned to medtronic for analysis.The device was received with the both the actuator and carriage components detached from the dcs.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.A kink on the inner member shaft was observed.Inner member shaft kinks have historically been seen on device returns when the dcs is returned with the capsule partially open and the inner m ember shaft not supported by the stylet, as was observed in this case.The tabs and hooks on the actuator components were observed to be detached.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.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the handle on the delivery catheter system (dcs) separated during the third attempt to recapture the valve.At that point it was not possible to deploy the valve.The capsule was just over the prosthesis about 5 mm from prior to total recapture.After the handle separated a broken tab was present that was not present in the packaging.The deployment trigger was not used at any point in the process.There was no unusual tension in the system and the handle was not over-driven.The valve loader was experienced.Following the handle separation, the dcs was carefully removed from the patient's body and a second valve and dcs was used to successfully implant the valve.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: 22442280
• Report Number: 2025587-2025-04843
• Device Sequence Number: 8028934
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: (01)00643169987210(17)200423(10)0009104041
• 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): 07/08/2025

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: 04/23/2020
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009104041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• 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: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2018
• 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: 88 YR
• Patient Sex: Male