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

Model Number TF-27A

Device Problem Defective Component (2292)

Patient Problems Pulmonary Regurgitation (2023); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the product ifu, the trifecta valve is indicated as a replacement for a diseased, damaged or malfunctioning native or prosthetic aortic heart valve.

Event Description

On (b)(6) 2014, a patient underwent a pulmonary valve replacement with a 27mm trifecta valve.On (b)(6) 2014, a maximum gradient of 26mmhg was observed on echo.On (b)(6) 2014, the maximum gradient was 26mmhg with a mean gradient of 15mmhg by echo.On (b)(6) 2015 the maximum gradient was 40mmhg with a mean gradient of 25mmhg on echo.On (b)(6) 2015 the max gradient was 52mmhg with a mean gradient 29mmhg on echo.Stenosis and pulmonary regurgitation were reported secondary to suspected valve deterioration.The patient underwent a pulmonary valve-in-valve procedure on (b)(6) 2016.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5488973
• MDR Text Key: 39976599
• Report Number: 3007113487-2016-00025
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 25 YR