MAUDE Adverse Event Report: ST JUDE MEDICAL; HEART-VALVE, MECHANICAL

Device Problems Sticking (1597); Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

Pt had a st.Jude aortic valve explanted today and replaced with a pericardial tissue valve.The valve was implanted eleven months ago.Fluoroscopy noted one of the leaflets of the st jude mechanical prosthesis was not opening up.

• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST JUDE MEDICAL; 177 county road b east; little canada MN 55117
• MDR Report Key: 4336639
• MDR Text Key: 5141414
• Report Number: 4336639
• Device Sequence Number: 1
• Product Code: LWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/14/2014

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: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1