MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC. 23MM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A-IDE

Device Problem Missing Information (4053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  Injury  

Event Description

On (b)(6) 2008, a 23mm trifecta valve was implanted.On (b)(6) 2017, a valve-in-valve procedure was completed with an unknown tavi valve placed within the failing 9-year-old surgical valve.Of note, on (b)(6) 2018, follow up was completed and the patient reports the tavi procedure has failed and that in 2019 the md will see the patient again for further treatment options.Additional information has been requested.The patient was reported stable.The patient's past medical history include hypertension, type 2 dm, copd, and post cabg.(clinical study patient id: (b)(6)).

Event Description

On (b)(6) 2008, a 23mm trifecta valve was implanted.On (b)(6) 2017, a valve-in-valve procedure was completed with an unknown tavi valve placed within the failing 9-year-old surgical valve.Of note, on (b)(6) 2018, follow up was completed and the patient reports the tavi procedure has failed and that in 2019 the md will see the patient again for further treatment options.Additional information was requested, but not available.The patient was reported stable.The patient's past medical history include hypertension, type 2 dm, copd, and post cabg.(clinical study patient id: (b)(6)).

Manufacturer Narrative

An event of a valve-in-valve procedure was reported.The results of the investigation are inconclusive since the device was not returned for analysis and remains implanted.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.Information from the field indicated that the valve has been implanted for 9 years and the patient had a past medical history of hypertension, type 2 dm, copd, and post cabg.

• Brand Name: 23MM 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
• MDR Report Key: 8217780
• MDR Text Key: 132089933
• Report Number: 8020430-2019-00001
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-23A-IDE
• Device Catalogue Number: TF-23A-IDE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR