MAUDE Adverse Event Report: ST. JUDE MEDICAL TORONTO; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Partial Blockage (1065)

Patient Problem Valvular Stenosis (2697)

Event Type  Injury  

Event Description

Medtronic received information that a core valve transcatheter bioprosthetic valve was implanted valve-in-valve in to a stenotic st.Jude medical toronto-tspv-25mm.The implant was successful and no adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TORONTO
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17517621
• MDR Text Key: 321049961
• Report Number: MW5124569
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1