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

Model Number ENVEOR-N-US

Device Problems Positioning Failure (1158); Kinked (1339); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the valve loaded in the capsule of the dcs.The handle was intact, and the trigger moved to fully advanced and retracted position and locked in place when released.The tip-retrieval mechanism was intact, and the device was returned with the end cap/screw gear snap fit connected.There was damage observed on the threading of the screw gear and the proximal end of the capsule was observed to have separated.Voids were observed at the separation site and the separation site was jagged and uneven.The valve was not able to be removed from the dcs.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve a misload was suspected.The capsule was pulled back to release the valve.The valve was reloaded and the capsule kinked and tore and the valve could not be released.No resistance was felt during the loading.A second valve was loaded to a second delivery catheter system (dcs) and used for implant.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion: analysis confirmed that the capsule separated at the proximal end.Additionally, voids were observed on the capsule, which indicate delamination between the capsule outer polymer and the nitinol frame, and typically occur when the capsule is subjected to a bending force potentially if a valve has been misloaded.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.Overall, there were no findings to suggest a failure to meet manufacturing specifications.Capsule separation typically occurs due to excessive compressive forces applied during the valve loading process.This excessive compressive force is experienced when the valve is loaded incorrectly.The initial misload reported in this event may have caused the capsule damage, or the reload of the valve onto the same dcs after the misload was identified may have resulted in capsule damage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENVEO R DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7408200
• MDR Text Key: 104825924
• Report Number: 2025587-2018-00813
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008911902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR