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); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was loaded in the capsule of the delivery catheter system (dcs).The capsule was fully closed and slightly over-captured.Several voids were observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.The capsule reinforcement frame was separated but held together by the polymer at the proximal end of the capsule.The device was returned with the end cap/screw gear snap fit connected.Conclusion: the investigation is in progress.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, due to a tortuous descending aorta and abdominal aortic aneurysm graft, there was difficulty advancing the delivery catheter system (dcs) to the ascending aorta.Once the dcs was positioned in the aorta, visual disruption of the proximal capsule was noted.It was reported an area of the capsule appeared less opaque under fluoroscopy.An x-ray showed the area of concern as "twisted/stretched." the delivery handle was rotated two turns and the dcs would not perform.The dcs was removed from the patient.No adverse patient effects were reported.
Additional Manufacturer Narrative
A device history record (dhr) review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Conclusion: difficulty advancing the dcs through patient anatomy was known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, it was noted that the aorta was tortuous and the patient had an abdominal aortic aneurysm graft.This indicated that the probable cause of the advancement difficulties was patient anatomy and the existing graft.Advancement difficulties do not typically indicate a device issue.The dcs was returned to medtronic for analysis.The device was received slightly over captured.The evolutr ifu, cautioned the user to ¿stop advancing the capsule once the gap to the catheter tip is closed.Advancing the capsule farther could damage the capsule¿.Analysis of the subject dcs confirmed the break at the proximal end of the capsule, with the capsule polymer still covering the broken capsule frame.Capsule separation typically occurred due to excessive compressive forces applied during the valve loading process.This excessive compressive force was only experienced when the valve was loaded incorrectly.It could not be determined if the valve was correctly loaded onto the dcs.It was reported that the delivery handle was rotated two turns and the dcs would not perform.This was consistent with capsule separation events where the capsule damage results in being unable to deploy the valve.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: 7087734
• Report Number: 2025587-2017-02362
• Device Sequence Number: 1466548
• Product Code: NPT
• UDI-Device Identifier: 00643169640337
• UDI-Public: 00643169640337
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/12/2018

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: 01/13/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008450383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR