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

Model Number ENVEOR-US

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

Delivery system device was opened on sterile back table.Medtronic rep scrubbed and received the device.She noticed that the handle was not "right" and was not working properly.Device removed from back table and another obtained.Never touched the patient.

• Brand Name: ENVEO¿ R
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 east deere ave.; santa ana CA 92705
• MDR Report Key: 6885991
• MDR Text Key: 87019574
• Report Number: 6885991
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017,09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/20/2018
• Device Model Number: ENVEOR-US
• Device Lot Number: 0008459325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT.