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	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve appeared constrained and under-expanded.The valve was recaptured and during the second deployment of the valve, it was noted that the valve appeared constrained.It was decided to recapture the valve and to perform a balloon aortic valvuloplasty (bav).However, upon recapturing the valve at about 60%, the blue handle of the delivery catheter system (dcs) broke into two parts.The handle was manually put back together and the valve was recaptured and removed from the patient.It was reported that no tension was felt in the system.A new valve and dcs were used for implant.No adverse patient effects were reported.
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 detached from the dcs, the capsule partially opened, 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 of the capsule.A kink was observed at the midpoint of the inner member.The tabs were detached from the male deployment knob component.Damage was observed on the male actuator component near the detachment site of the tabs and near one of the hooks.During functional testing, the trigger moved to fully advanced and retracted positions and locked in place when released.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.The suspect dcs was returned to medtronic for analysis with the actuator components detached, which confirmed the reported event.Delamination typically occurs when the capsule is subjected to a bending force potentially after tracking through the patient anatomy.A kink was observed on the inner member shaft.The description of the event does not indicate this kink occurred during the reported issue.Inner member shaft kinks have historically been seen on device returned with the capsule partially open as was observed in this case; the cause of this damage 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.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.

• 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: 22473138
• Report Number: 2025587-2025-04910
• Device Sequence Number: 4272437
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: (01)00643169956193(17)190721(10)0008723967
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 07/10/2025

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: 07/21/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008723967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• 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: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2017
• 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 Sex: Male