MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-25A-IDE

Device Problem Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 09/23/2016

Event Type  Injury  

Event Description

On (b)(6) 2008, a 25mm trifecta valve was implanted.The patient developed severe prosthetic aortic stenosis, aortic insufficiency, and regurgitation.On (b)(6) 2016, redo-avr replacement for macce (major adverse cardiovascular and cerebrovascular event) reduction was performed.The patient underwent urgent inpatient redo-sternotomy and redo-avr for structural valve degeneration.Per report, the patient is doing well 2 months post redo-avr, and is able to walk with some shortness of breath.No recurrent angina reported.(study patient id: (b)(4)).

Manufacturer Narrative

Product evaluation: an event of "prosthetic aortic stenosis, aortic insufficiency, and regurgitation" was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer (Section G): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer Contact: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7144417
• MDR Text Key: 95693628
• Report Number: 8020430-2017-00023
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2009
• Device Model Number: TF-25A-IDE
• Device Catalogue Number: TF-25A-IDE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention