MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	ENVEOR-US
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The first valve and delivery catheter system (dcs) dislodge were reported on a separate medwatch.This device was expected for return, a supplemental report will be sent upon completion of the analysis.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 positioned above the annulus.During removal of the delivery catheter system (dcs), the nose cone of the dcs became stuck in the valve struts and dislodged the valve into the ascending aorta.A second transcatheter bioprosthetic valve was attempted to be implanted valve-in-valve with th is second dcs.During deployment of the second valve, tension was felt and the valve dislodged upward.Following recapture of the valve, the handle of the dcs was spinning and unable to redeploy the valve.The capsule of the second dcs was broken.The second valve and the second dcs were withdrawn from the body.Upon direct visualization, the valve was unable to be removed from the dcs and a capsule break was noted near the inline sheath.Another transcatheter bioprosthetic valve, was then successfully implanted in the aortic annulus with a third dcs.The patient was reported to be stable after successful valve implant.
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 dcs handle and the tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.The proximal end of the capsule was separated.The separation site was jagged and uneven.Voids were observed along the proximal end of the capsule.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.Fluoroscopy checks performed on the returned device did not indicate a paddle out of pocket misload.However, analysis conducted by borescope showed track marks from interaction of the paddle with the capsule liner.This is consistent with damage during a misload.When a valve is loaded correctly onto a delivery catheter system (dcs), the valve paddles are seated within the pockets of the spindle and the capsule is positioned over the assembly.If the paddles are not seated correctly, they sit proud of the spindle pocket, increasing the outer diameter of the assembly.If left uncorrected, additional force may be applied through the capsule, damaging the system.Capsule damage initiated during the loading process is not always identified during inspections to confirm a correct load and absence of capsule damage.If the defects are not identified during loading, the tensile force applied during deployment can lead to the capsule polymer stretching or the capsule detaching.When a capsule separation occurs, the capsule may not deploy the valve, which is consistent with the report of unable to deploy in this event.Typically, capsule separation occurs due to excessive compressive forces applied during the valve loading process and the capsule then separates when tension is applied.This excessive compressive force is experienced when a misload occurs and is consistent with the misload observed on the returned product.Overall, there were no findings to suggest a device quality deficiency related to the manufacturing of the device.Based on the evidence available, the root cause of the capsule separation cannot be conclusively determined in this case.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: 7241613
• Report Number: 2025587-2018-00301
• Device Sequence Number: 882552
• Product Code: NPT
• UDI-Device Identifier: 00643169800915
• UDI-Public: 00643169800915
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/10/2018

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: 08/22/2018
• Device Model Number: ENVEOR-US
• Device Catalogue Number: ENVEOR-US
• Device Lot Number: 0008765153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/23/2018; 09/05/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/15/2018; 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 81 YR