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

Model Number ENVEOR-N

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467); Device Dislodged or Dislocated (2923)

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

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) the handle was intact.The device was received with the capsule partially open.The deployment knob retracted and advanced the capsule.The trigger moved to fully advance and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The device was returned with the end cap/screw gear snap fit connected.There was damage noticed on the threading of the screw gear.Several voids were noted over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.The capsule reinforcement frame was separated but held together by the polymer at the proximal end of the capsule.There was a kink along the proximal end of the inner member shaft near the paddle attachment pockets.The dhr review was performed on the device; 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.It was reported that the valve was recaptured four (4) times due to positioning difficulties.Various factors could effect valve positioning, such as patient anatomy or physician experience.The cause of the suboptimal placement could not be determined.The recapture feature of the enveor device allowed for additional attempts at accurately positioning the valve.It was reported that, during the fourth attempt at recapturing the valve, the capsule kinked and the system was withdrawn from the body with the valve partially exposed.It was possible that the positioning difficulties and multiple recapture attempts may have contributed to this event, as the device ifu instructs the user to recapture the valve for a maximum of three (3) times.An assignable root cause could not be determined at this time.The capsule damage proximal to the spindle hub, screw gear threads, inner member shaft, and the capsule, suggested excessive force applied on the system.Capsule damage typically occurred due to excessive compressive forces applied during the valve loading and/or deployment.This excessive compressive force was typically experienced when the valve was loaded incorrectly.In this case, it could not be determined if the valve was correctly loaded onto the dcs.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve into an annulus with pure aortic in sufficiency, the valve dislodged despite several attempts to reposition.After the fourth recapture, the deployment knob would not respond.A heavy kink on the distal end of the capsule was observed near the paddle attachment.The delivery catheter system (dcs) was pulled back to the iliac level and withdrawn from the body with the valve partially open.It was reported that the dcs may have been over-driven during the recaptures.The procedure was aborted.No adverse patient effects were reported.

• 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: 7472710
• MDR Text Key: 106963292
• Report Number: 2025587-2018-01015
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0008737459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 80