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	Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.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 with this delivery catheter system (dcs), the valve was deployed and recaptured four times successfully.During the fifth deployment attempt, the capsule was not retracting, and a capsule separation occurred.The system was removed carefully through arteriotomy causing no injury to the vessel.A new valve and dcs was prepped and successfully deployed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received reported that the valve was deployed and recaptured three times successfully.During the fourth deployment attempt, the capsule was not retracting, and a capsule separation occurred.The valve was fully recaptured prior to removal.It was noted that a steep root angle was encountered, which required a fair amount of torque on the catheter.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
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 device was received with the capsule partially open.The handle appeared intact.The trigger moved to fully advance and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.Several voids were observed over the nitinol reinforcing frame along the length of the capsule.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was jagged and uneven.The capsule appeared bent or bowed.The valve cannot be removed from the dcs.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.It was reported that the valve was placed at a suboptimal position, was recaptured three times, and deployment was attempted four times.Various factors can affect valve positioning, such as patient anatomy or physician experience; the cause of the suboptimal placement could not be determined with the limited information available.The recapture is a feature of the enveor device that allows for additional attempts at accurately positioning the valve; however, the device instructions for use (ifu) instruct the user to a maximum of three recaptures, which then warrants withdrawal of the valve from the patient.In this case, the valve was deployed a fourth time against ifu recommendations, and a capsule separation occurred warranting withdrawal of the device.It is possible that the fourth deployment attempt may have resulted in excessive force on the system leading to the capsule separation, in addition to the reported aortic root angulation.However, without review of procedural images, the series of events leading to the capsule separation cannot be assessed, and an assignable root cause cannot be determined.Evaluation of the returned device confirmed the capsule separation; several voids were observed over the nitinol reinforcing frame along the length of the capsule, and a break was observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was jagged and uneven.The capsule appeared bent or bowed.The valve could not be removed from the delivery catheter system (dcs).These observations on the returned dcs 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 was misloaded.Capsule separation typically occurs due to excessive compressive forces applied during the valve loading process.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: 7410780
• Report Number: 2025587-2018-00821
• Device Sequence Number: 13796272
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/05/2018

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: 11/14/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008880067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018; 04/30/2018; 08/16/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/10/2018; 05/21/2018; 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR