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	Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2017
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.One of the tabs is observed to be detached from the male deployment knob.The other tab appears to be hinging inwards.The tip-retrieval mechanism appears intact.The distal edge of the capsule seats flush against the catheter tip when fully advanced.The capsule appears intact with no evidence of damage.The spindle hub appears intact with no evidence of damage.Kinks are observed all along the inner member, the worst kink is at the proximal end near the spindle hub.The device was returned with the end cap/screw gear snap fit connected.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.It was reported that the valve was misloaded.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the device instructions for use (ifu), contains instructions to use the integrated loading bath which features a mirror to aid in accurate placement of the tav frame paddles during loading.The user is instructed to not advance the capsule over the frame paddles unless they are fully seated in the center of the paddle pockets in order to avoid damage to the capsule and to avoid emboli.The ifu instructs to inspect the valve under fluoroscopy, and in addition, the ifu instructs to visually and tactilely inspect the capsule for a misloaded bioprosthesis.In this case, the inspection process per the ifu properly identified the misload prior to introduction to the patient.It was reported that the deployment knob (actuator) separated during loading.The subject dcs was returned for analysis.There was no evidence of capsule bumps, bending or delamination (discoloration) observed on the subject device, and the reported misload could not be confirmed via analysis of the returned device.Inner member shaft kinks were observed, however the description of the event does not indicate that 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 the event occurred, or when there was no stylet in place during return transport, as was observed in this case.The subject dcs was returned with the deployment knob separated, confirming the reported event.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 prior to the implant of this transcatheter bioprosthetic valve, while loading the valve and the clear tube was removed, it was reported that the valve was misloaded.It was noted that the paddle was out of pocket.On the second load turn, the handle fell off.The delivery catheter system (dcs) was not used and the valve was loaded onto a different dcs for implant.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: 22345207
• Report Number: 2025587-2025-04593
• Device Sequence Number: 8573257
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: 00643169956193
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/27/2025

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: 06/28/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008693410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• 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: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2017
• 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