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); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2019
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 dcs was received with the valve loaded in the capsule of the dcs, the actuator components were partially separated, the end cap/screw gear snap fit was connected, the capsule fully closed and slightly over captured.Visual analysis showed the handle was not intact.The tip-retrieval mechanism appeared intact.Damage was observed on the screw gear of the device.The capsule appeared slightly bent or bowed.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule.During functional testing, when attempting to retract the capsule using the deployment knobs, the capsule started to buckle and then bent.The actuator components fully separated during the attempted retraction of the capsule.Both tab 3 and tab 4 of the male actuator component had a crack at the point where the tab protrudes from the actuator component.The valve could not be removed from the dcs.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 dcs that allows 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 of the positioning difficulty could not be conclusively determined with the available evidence.The suspect dcs was returned for analysis with the valve inside the dcs capsule.The actuator components were separated which confirmed the event.Delamination typically occurs when the capsule is subjected to a bending force potentially after tracking through patient anatomy.When the capsule was retracted during analysis, the capsule bent.The dry valve and inside the capsule most likely resulted in the friction leading to the capsule bending during analysis.Damage to the threading of the screw gear indicates there was increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.The force in the system is a cumulative effect that can be increased by many other factors, including load quality of the valve in the capsule, bends and kinks on the shaft, tortuous anatomy and guidewire and sheath selection.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 delivery catheter system (dcs) handle broke during a partial recapture when the handle was two-thirds closed.The handle was snapped back on the dcs and although there was reported difficulty in recapturing the valve, the valve was recaptured and the system was withdrawn safely.The valve was recaptured due to an inadequate implant depth.The valve was replaced to due to partial deployment in the body and a second valve was implanted uneventfully.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: 22507075
• Report Number: 2025587-2025-05016
• Device Sequence Number: 18327069
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: (01)00643169987210(17)210429(10)0009718678
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/15/2025

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: 04/29/2021
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009718678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• 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: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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 Sex: Female