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); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made 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 this transcatheter bioprosthetic valve, tension built up in the delivery catheter system (dcs) due to severe tortuously of the aorta.It was noted that the dcs capsule was buckling and the system was immediately removed from the patient.When an attempt was made to retrieve the valve from the damaged dcs, the capsule broke.Subsequently , the dcs was not used for the implant and the procedure was successfully completed using another dcs.It was reported that the patient had undergone a previous ross procedure and had mildly calcified anatomy.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received that the loading was performed by inexperienced hospital staff but supervised by medtronic personnel.No resistance was felt during loading.During attempted implant, the valve was partially deployed twice and recaptured due to repositioning.When the buckling occurred, a third full recapture was performed to remove the system from the patient.It was reported a challenging procedure was expected by the implanting team during pre-implant planning due to the severe tortuosity and anomalous anatomy.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.Images provided and reviewed confirmed a capsule buckle in the patient as well as a separated capsule outside the patient.Capsule separation typically occurs due to excessive compressive forces applied during the valve loading and/or deployment process.However, there were no fluoroscopic images submitted for review, thus the series of events leading to the capsule buckle cannot be assessed at this time.Various factors can affect valve positioning, such as patient anatomy or physician experience, and the cause of the suboptimal placement could not be determined with the limited information available.Recapturing is a feature of the device that allows for additional attempts at accurately positioning 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: 7507702
• Report Number: 2025587-2018-01109
• Device Sequence Number: 2073820
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• 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,Followup
• Report Date (Section B): 10/02/2018

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: 11/17/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008886111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 09/13/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 05/23/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 64