MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA BIOPROSTHESIS ATRIAL VALVE; HEART VALVE, MECHANICAL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 07/15/2019

Event Type  malfunction  

Event Description

Valve with tear in the non-coronary leaflet removed by surgeon.The pt had initial valve replacement done in (b)(6) 2014.The pt was doing well until (b)(6) 2018 when she developed orthopnea, wheezing and gradual decrease exercise intolerance and a new murmur noted.The suggestive of tear and underwent redo avr.

• Brand Name: TRIFECTA BIOPROSTHESIS ATRIAL VALVE
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 8916018
• MDR Text Key: 155334198
• Report Number: MW5089228
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 63