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

Model Number ENVEOR-N

Device Problems Kinked (1339); Difficult To Position (1467); Material Separation (1562)

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

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) capsule was fully closed.The handle was intact.The deployment knob was able to retract and advance 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.Several voids were observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.There was damage to the nitinol frame near the proximal end of the capsule.The inner member shaft and the spindle hub was intact with no evidence of damage.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.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.Angiographic records submitted from the hospital for review showed during that the first attempt to deploy the valve into the aortic position, the valve had been deployed approximately 1 cm and there was already a kink noted in the device.The films showed that the valve was 80% deployed and was in an unacceptable position too high in the annulus.The film showed the valve fully recaptured with the capsule now kinked.The next film indicates the clinician continued to turn the deployment knob and the capsule appeared separated.The subject delivery catheter system (dcs) was returned to medtronic for analysis.Voids observed on the capsule 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 has been misloaded.Damage to the nitinol frame near the proximal end of the capsule was observed, which indicated the nitinol frame was fractured and is consistent with the capsule separation observed in the films.No other evidence of damage was observed on the dcs.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 angiographic records submitted for review show that the valve was loaded correctly.Therefore, the root cause of the capsule break in this case cannot be determined.Medtronic will continue to monitor the field for similar events.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, a fluoroscopy check revealed a successful load on the first attempt.The delivery catheter system (dcs) was inserted via direct aortic access.The valve was 80% deployed and was recaptured due to high deployment and the dcs was not parallel to the ascending aorta's wall.The dcs was pushed firmly in order to obtain a better alignment with a consequent bend of the capsule.At 80% the valve was slightly bent just below the paddle attachment and was recaptured in this configuration.While recapturing the valve, a fracture of the capsule was noted.The physician released the valve successfully.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: 7466136
• MDR Text Key: 106741172
• Report Number: 2025587-2018-00995
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2018
• Device Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0008545655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Date Device Manufactured: 03/22/2017
• 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