MAUDE Adverse Event Report: ST. JUDE MEDICAL REGENT MECHANICAL VALVE; MECHANICAL HEART VALVE

Model Number 23AGFN-756

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

St.Jude medical regent mechanical heart valve was noted to be not opening properly.The surgeon attempted to rotate the valve within the aorta, but was unsuccessful.The valve was determined to be defective and removed for replacement with another type of valve.During removal the patient sustained a ventricular tear which required repair.The defective valve was replaced with a 23mm st.Jude epic supra tissue valve.

• Brand Name: REGENT MECHANICAL VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7153997
• MDR Text Key: 96031056
• Report Number: 7153997
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/25/2022
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 99