MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; NONE

Device Problem Explanted (1217)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  Other  

Event Description

Medtronic mosaic aortic valve size 25 mm was implanted.A tee immediately post implantation showed the valve was not effective.The valve was explanted and another was implanted.The company was notified and the defective valve was returned to the company through the company representative.

• Brand Name: MEDTRONIC
• Type of Device: NONE
• Manufacturer (Section D): MEDTRONIC; 710 medtronic parkway; minneapolis MN 55433
• MDR Report Key: 4532258
• MDR Text Key: 5541701
• Report Number: 4532258
• Device Sequence Number: 1
• Product Code: LWR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: 25 MM SIZE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2014
• Distributor Facility Aware Date: 09/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other