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

Model Number	ENVEOR-US
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2015
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, visual analysis showed the handle of the delivery catheter system (dcs) appeared damaged or broken with the blue micro control handle detached or separated from the device.Two blue components were received with the device for analysis.A stress mark was observed on both micro control snap fit side tabs along the flexible edge but remained intact.No gouge marks were observed inside both micro control handle components.The micro control appeared to retract and advance the capsule without the components attached.The macro control moved to fully advanced and retracted positions with slight difficulty without the micro control components attached.The tip retraction mechanism appeared intact.Note: the screw gear snap fit remained connected.The distal tip of the capsule seats flush against the tip ledger when fully advanced.The capsule appeared intact with no evidence of distortion or damage.The inner member shaft appeared intact with no evidence of damage.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.Restricted use (ru) form 4374 was noted in the dhr.Ru# 4374 indicated a visual sort of the left actuator components occurred.This ru is directly related to this event; this sort was performed to remove any devices that may have had damage to the snap fit tabs on the actuator parts that make up the deployment knob.This ru indicates these parts went through the sort process, and no damage was found at the time of the sort.Therefore, the dhr review indicates this event does not appear to be related to the supplied condition of the reported parts.The dhr review did not yield any findings that may have indicated a manufacturing related cause for this event.The reported information indicated the snap fit connecting the actuator parts that make up the dcs deployment knob failed while loading a valve.The dcs was returned for analysis and the handle was received broken with the actuator parts separate from the device, confirming the reported event.A stress mark was observed on both actuator snap fit side tabs along the flexible edge, but these tabs remained intact.All mechanisms appeared to function as intended, or with slight difficulty due to the detached actuator parts.The analysis confirmed the event, but did not yield any findings that would indicate a root cause.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 14 years 11 months post implant of this aortic bioprosthetic valved conduit, the valve was replaced valve-in-valve with a medtronic transcatheter valve due to moderate central regurgitation.During implant of the first transcatheter valve, the valve dislodged above the annulus resulting in severe paravalvular leak (pvl).The valve remains in the patient.A second transcatheter valve was implanted.During loading of the second valve, the handle of the delivery catheter system (dcs) came apart while turning the handle.The valve was unloaded and successfully loaded onto a new dcs and was successfully implanted valve-in-valve.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: 22358113
• Report Number: 2025587-2025-04621
• Device Sequence Number: 20853609
• Product Code: NPT
• UDI-Device Identifier: 00643169633353
• UDI-Public: (01)00643169633353(17)160927(10)0007764114
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 09/27/2016
• Device Model Number: ENVEOR-US
• Device Catalogue Number: ENVEOR-US
• Device Lot Number: 0007764114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• 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: 09/28/2015
• 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: 83 YR
• Patient Sex: Female