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

Model Number TF-23A

Device Problem Missing Information (4053)

Patient Problem No Information (3190)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2011, a 23 mm trifecta valve was implanted.On (b)(6) 2018, structural valve deterioration was observed and the valve was exchanged for a 23 mm corevalve evolut r valve.No patient consequences were reported.(clinical study patient id: (b)(6)).

Event Description

On (b)(6) 2011, a 23mm trifecta valve was implanted.On (b)(6) 2018, structural valve deterioration was observed and the valve was exchanged for a 23mm corevalve evolut r valve.No patient consequences were reported.(clinical study patient id: (b)(6).

Manufacturer Narrative

An event of stenosis and decreased leaflet mobility due to structural valve deterioration was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8731922
• MDR Text Key: 149110348
• Report Number: 3008452825-2019-00286
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2012
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3278475
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 79