MAUDE Adverse Event Report: ST JUDE/ABBOTT MEDICAL TRIFECTA; HEART VALVE MECHANICAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Insufficiency (1715); Failure of Implant (1924)

Event Date 11/26/2019

Event Type  Injury  

Event Description

St jude trifecta aortic valve prosthesis failed due to aortic insufficiency prematurely.Fda safety report id (b)(4).

• Brand Name: TRIFECTA
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ST JUDE/ABBOTT MEDICAL
• MDR Report Key: 9391832
• MDR Text Key: 168463470
• Report Number: MW5091362
• 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: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• 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 Outcome(s): Life Threatening
• Patient Age: 77 YR
• Patient Weight: 85