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	Difficult or Delayed Positioning (1157); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2017
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 delivery catheter system (dcs) at medtronic's quality laboratory, the device was received with the handle components detached from the dcs.One of the tabs on the male deployment knob was observed to be hinged inwards.The other tab was detached and missing from the deployment knob.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.The device was received with the capsule fully closed.The distal edge of the capsule seats flush against the catheter tip when fully advanced.Some voids were observed over the nitinol reinforcing frame at the proximal end of the capsule.The inner member and spindle hub appeared intact with no evidence of damage.There was a severe kink observed on the stability member, the kink was at the mid-point of the stability shaft.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.Recapturing is a feature of the system to allow for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications; the cause could not be determined.It was reported that the deployment knob (actuator) separated during recapture.The suspect dcs was returned to medtronic for analysis which confirmed the actuator separation.One of the tabs on the deployment knob was damaged and the other tab was missing.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.Voids were observed on the capsule, which indicate delamination between the capsule outer polymer and the nitinol frame.Voids typically occur when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy or if a valve has been misloaded.The cause of the voids in this case could not be conclusively determined.A kink was observed in the stability shaft of the dcs; however, the description of the event does not indicate this damage occurred during the reported issue.The kink may have occurred in transit when the device was returned for analysis; however, the cause of the kink 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.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was 80% deployed and it was reported the valve was shallow.While recapturing the valve, a "pop" sound was heard.The valve was completely recaptured and the blue handle fell apart on the delivery catheter system (dcs).The dcs and valve were removed and a new valve and dcs were used.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: 22360703
• Report Number: 2025587-2025-04636
• Device Sequence Number: 8655453
• Product Code: NPT
• UDI-Device Identifier: 00643169633353
• UDI-Public: (01)00643169633353(17)180529(10)0008653235
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 05/29/2018
• Device Model Number: ENVEOR-US
• Device Catalogue Number: ENVEOR-US
• Device Lot Number: 0008653235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• 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: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2017
• 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 Age: 83 YR
• Patient Sex: Male