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

Model Number TF-23A

Device Problems Backflow (1064); Calcified (1077); Material Split, Cut or Torn (4008)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/04/2021

Event Type  Injury  

Manufacturer Narrative

An event of regurgitation, a leaflet tear and calcification was reported.A more comprehensive assessment could not be performed as the device 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that on (b)(6) 2012, a 23 mm st.Jude medical (sjm) trifecta valve was implanted into patient's aortic valve.On (b)(6) 2021, the valve was explanted and replaced with a 23 mm non-abbott aortic valve.The valve was replaced due to severe aortic regurgitation (ar).No information available as to how the ar was detected.It was reported that there was a tear and mild calcification seen on the explanted valve.No signs of interaction between stent posts and patient anatomy were reported.The patient was reported to be recovering uneventfully in post-operative phase.No additional information available regarding this event.

• 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 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12256845
• MDR Text Key: 264474857
• Report Number: 3014918977-2021-00042
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2013
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3644057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2021
• Initial Date FDA Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2011
• 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