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

Model Number ENVEOR-N-US

Device Problems Fracture (1260); Positioning Problem (3009)

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

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Conclusion: various factors can affect valve positioning, such as patient anatomy or the physician experience.It was reported that the valve was recaptured three times in order to re-position the valve for deployment.This is a feature of the device that allows for additional attempts at accurately positioning the valve.The cause of the suboptimal placement could not be determined with the limited information available.It was also indicated that the capsule fractured when deployed on the table outside the patient.An image of the fractured capsule was provided and confirmed the event.Capsule damage or separation is typically related to a misloaded valve or other source of forces created on the system, which is then exacerbated during tracking or deployment.However, without review of fluoroscopic load check and/or procedural imaging, the quality of the valve loading process could not be assessed, and an assignable root cause cannot be determined.The lot history was reviewed and showed; 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, three attempts were made to properly position the valve.The valve was recaptured each time and the device was withdrawn from the body.Upon attempting to deploy the valve on the back table, the capsule fractured.A different valve was loaded into another dcs and was successfully implanted.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: 7283368
• MDR Text Key: 100568894
• Report Number: 2025587-2018-00422
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: 00643169956193
• 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
• Report Date: 02/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008602084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 02/20/2018
• Date Device Manufactured: 04/26/2017
• 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: 81 YR
• Patient Weight: 106