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	Material Separation (1562); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the valve was received loaded in the capsule of the delivery catheter system (dcs).The delivery catheter system was returned with the flush hub cap components detached.The deployment handle was intact.Several voids were observed over the nitinol reinforcing frame along the proximal end of the capsule to the end-section of the capsule.The capsule was broken and separated at the proximal end.The stability shaft was badly kinked mid-way on the shaft.On attempted retraction of the capsule via the rotation of the deployment knob, the capsule did not deploy the valve.The device was returned with the end cap/screw gear snap fit connected.Conclusion: the lot 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 damage typically occurs due to excessive compressive forces applied during the valve loading process.This excessive compressive force is only experienced when the valve is loaded incorrectly.In this case, there were no fluoroscopic load check images submitted for review, therefore it cannot be independently determined if the valve was correctly loaded onto the delivery catheter system (dcs).The valve was recaptured a fourth time.The device instructions for use (ifu) instruct the user to recapture the valve for a maximum of three (3) times; it is possible that user factors may have contributed to the capsule separation.Additionally, there were no procedural cine/angio films provided, thus the positioning attempts and subsequent damages could not be confirmed of further assessed at this time.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 a transcatheter bioprosthetic valve, into a tortuous anatomy and a tortuou s ascending aorta, it was reported the capsule was bent on the second valve recapture.On the fourth recapture, the capsule showed damage on fluoroscopy.The delivery catheter system (dcs) and valve were removed from the patient.A new valve was loaded onto a new delivery catheter system and was deployed successfully.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: 7469864
• Report Number: 2025587-2018-01011
• Device Sequence Number: 1274019
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: 00643169956193
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 04/27/2018

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: 07/06/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008703464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR