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	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was prepared and loaded onto the delivery catheter system (dcs) without incident.Fluoroscopic inspection was performed and indicated a successful load.The system was introduced over a non-medtronic guidewire using an inline sheath.The dcs was advanced through the patient's unremarkable anatomy, over the aortic arch, and through the aortic valve.The valve was deployed to 80%, but the valve frame was constrained from the opening due to heavy calcification.The valve was attempted to be recaptured.During this recapture, the actuator separated into two pieces with the valve 75% recaptured.The physician noted tension was felt in the dcs prior to the handle separating.The physician was able to ¿push the two clear tabs on the handle toward the grey hub¿ to completely recapture the valve, which was still in the aortic position.The valve and dcs were completely removed from the patient.A 16fr non-medtronic sheath replaced the dcs i n the left femoral artery.A second valve and second dcs were prepared, and the valve was successfully loaded; the second load was verified via fluoroscopic inspection.The aortic valve was pre-dilated using a 20mm balloon.The balloon was withdrawn and the new dcs was introduced over the non-medtronic guidewire using the inline sheath.The valve was deployed without incident.No adverse patient effects were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 dcs was received with the handle components and carriage components detached from the dcs, the capsule fully closed, and the end cap/screw gear snap fit connected.Visual analysis showed the tip-retrieval mechanism, capsule, inner member shaft, and spindle hub appeared intact with no evidence of damage.The nose cone tip appeared bent.A stress mark was observed on tab 4 at the point where the tab protrudes from the deployment knob.Tab 3 appeared to be hinging inwards.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 dcs was returned to medtronic for analysis with the actuator components and carriage components detached from the dcs.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.The carriage separation was most likely due to the actuator no longer securing the carriage components in place.The bend in the nose cone was observed; however, the description of the event does not indicate this damage occurred during the reported issue and the source of this damage could not be determined.Tension/force in the system is cumulative and many sources may contribute to the feeling of excess tension including load quality and packing density of the valve in the capsule, bends and kinks on the shaft, tortuous anatomy and guidewire and sheath selection.Ad ditionally, the amount of tension felt in the system is subjective and the feel of the device may be dependent on the user.The cause of the reported tension in the system could not be determined.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 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: 22501164
• Report Number: 2025587-2025-04989
• Device Sequence Number: 20583139
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: (01)00643169987210(17)210221(10)0009608258
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/14/2025

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: 02/21/2021
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009608258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• 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: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2019
• 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 Age: 79 YR
• Patient Sex: Male