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

Model Number TF-23A

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Aortic Insufficiency (1715); Thrombus (2101)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

An event of leaflet deterioration which the physician believed "was accelerated due to thrombus formation on the leaflets" 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.

Event Description

On (b)(6) 2013, a 23mm trifecta valve was implanted.On (b)(6) 2018, the valve had severe leaflet deterioration.The physician believes the deterioration process was accelerated due to thrombus formation on the leaflets.The hospital did not make the trifecta valve available for return.A livanova perceval valve was implanted as a replacement.The patient is reported to be stable.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7363611
• MDR Text Key: 103265000
• Report Number: 3007113487-2018-00008
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100029
• 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
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2014
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3792237
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2012
• 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): Hospitalization; Required Intervention