MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	ENVEOR-N-US
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: product id: ev olutpro-26-us, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4) coding for serial number (b)(4), (b)(4) product analysis: the valve remains implanted and the delivery catheter system (dcs) has not yet been received for analysis.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that following the implant of this transcatheter bioprosthetic valve, the nose cone of the delivery catheter system (dcs) was not centered and dislodged the valve out of the annulus while the dcs was withdrawn.The valve was snared into the ascending aorta.No additional adverse patient effects were reported for this device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENVEO R DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• MDR Report Key: 7733240
• Report Number: 2025587-2018-01934
• Device Sequence Number: 1018350
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008938616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 44