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	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned for analysis, however, the analysis has not yet been completed.Conclusion: without the completion of product analysis, 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 during the implant of a transcatheter bioprosthetic valve, the valve was recaptured.During reca pture, resistance was met while turning the delivery catheter system (dcs).The dcs was withdrawn from the body and a capsule separation was observed.A second valve was loaded to a second dcs and used for implant.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at medtronic's quality laboratory, the valve was received loaded in the capsule of the delivery catheter system (dcs).The handle appeared intact.The tip-retrieval mechanism appeared intact.Damage was observed on the threading of the screw gear.The device was returned with the end cap/screw gear snap fit connected.Voids were present on the capsule from the distal end to the proximal end.The proximal end of the capsule was observed to have separated.The separation site was jagged and uneven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion: 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.The valve was recaptured twice, which is a feature of the enveor delivery system to allow re-positioning of the valve.The report indicates that resistance was noted during recapture, and the valve was withdrawn from the body, where a capsule separation was observed.Capsule separation typically occurs due to excessive compressive forces applied during the valve loading process.This excessive compressive force is typically experienced when the valve is loaded incorrectly.The subject dcs and valve loaded inside were received and evaluated by medtronic; the damages observed on the screw gear suggest excessive forces applied on the system during rotating the knob, and the observed capsule voids indicate delamination between the capsule outer polymer and the nitinol frame, and typically occur when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy, or if a valve has been misloaded.In this case, there were no procedural cine/angio or load check images provided, therefore it cannot be independently determined if the valve was correctly loaded onto the dcs, and the series of events leading to the capsule separation could not be assessed.If information is provided in the future, a supplemental report will be issued.
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: 7286133
• Report Number: 2025587-2018-00428
• Device Sequence Number: 2116665
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 11/22/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008892354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 02/27/2018; 06/29/2018; 08/08/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/20/2018; 07/20/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1