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

Model Number TF-23A

Device Problems Torn Material (3024); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716)

Event Date 11/16/2017

Event Type  Injury  

Event Description

On (b)(6) 2014, a double valve replacement (dvr) was performed.A 23mm trifecta valve was implanted in the patient's aortic position and an unknown valve in mitral position.On (b)(6) 2017, the patient was admitted to the emergency room due to acute cardiac failure.Upon confirmation of severe aortic regurgitation (ar), re-do avr was urgently performed.The 23mmtrifecta valve was explanted, and a 23mm carpentier-edwards perimount magna aortic heart valve was implanted.Upon explant, one of the leaflets was noted to have been vertically torn and the valve became adhered to the aorta.The sewing cuff of the valve was damaged during explant.The surgeon assumes that uneven operational stress might have been placed on the valve, which may have resulted in the leaflet tear due to the adherence to the aorta.The patient is recovering, and making good progress.Patient specific information of birthdate and weight are not available for this complaint.

Manufacturer Narrative

An event of ¿aortic regurgitation¿ was reported.The results of this investigation concluded a tear in leaflet 3.There was circumferential fibrous pannus ingrowth on the inflow surface, which narrowed the inflow diameter.Leaflet 2 contained focal pannus on the outflow surface.No acute inflammation or significant calcifications were present in the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• 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
• 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7099715
• MDR Text Key: 94239248
• Report Number: 3008452825-2017-00306
• Device Sequence Number: 1
• Product Code: LWR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2016
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4526131
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• 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: 73 YR