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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
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 with a valve loaded in the capsule of the dcs, visual analysis showed the handle appeared intact.The device was received with the capsule fully closed and slightly over captured.The capsule appeared bent or bowed.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.Delamination was observed over the nitinol reinforcing frame along the full length of the capsule.On attempted retraction of the capsule via the rotation of the deployment knob, the valve deployed as expected.The inner member shaft and spindle hub appeared intact with no evidence of damage.The actuator separated once the valve was approx.80% deployed.Tab 3 was observed to have detached from the actuator.Tab 4 was observed to have a hairline crack at the point where the tab protrudes from the male actuator component.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.Conduction disturbances and hypotension are known potential adverse effects per the device instructions for use (ifu).Hypotension is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations.The dcs was returned to medtronic for analysis.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through patient anatomy.The capsule was slightly overcaptured on to the catheter tip.The ifu cautions the user to ¿stop advancing the capsule once the gap to the catheter tip is closed.Advancing the capsule farther could damage the capsule¿.The capsule also appeared bowed, which may have been caused by the overcapture.The dcs was received with the handle intact, however on attempted retraction of the capsule, the actuator separated.The snap fit tabs of the actu ator were observed to be broken and damaged.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, at 60% deployment, the blue handle of the delivery catheter system (dcs) broke in half and the valve could not be recaptured.The patient became asystolic with no blood pressure.Cardiopulmonary resuscitation was initiated for four minutes and epinephrine was administered.The handle of the dcs was put back together and the valve was recaptured.The patient recovered; the dcs and valve were withdrawn from the patient and not used for implant.Subsequently, a new dcs was used to successfully implant a new valve.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: 22506441
• Report Number: 2025587-2025-05009
• Device Sequence Number: 18467373
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: (01)00643169987210(17)210428(10)0009716568
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009716568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• 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: 04/29/2019
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 85 KG