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

Model Number	ENVEOR-N-US
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Capsule separation typically occurred due to excessive compressive forces applied during the valve loading process.This excessive compressive force was typically experienced when the valve was loaded incorrectly.An assignable root cause related to this event could not be determined.The subject device was not returned for evaluation, and the reported capsule separation could not be confirmed.The valve and dcs were recaptured and removed from the patient.A new valve was loaded onto a new dcs and the valve was successfully implanted.No adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was advanced, crossed the valve, and upon deployment the capsule did not move.It was reported that the capsule was broken and would not open.The valve and dcs were recaptured and withdrawn from the body.A new valve was loaded onto a new dcs and the valve was successfully implanted.No adverse patient effects were reported.

• 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: 7492564
• Report Number: 2025587-2018-01075
• Device Sequence Number: 145171
• Product Code: NPT
• UDI-Device Identifier: 00643169640337
• UDI-Public: 00643169640337
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/07/2018

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: 01/20/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008459338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR