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

Model Number TF-27A

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 11/23/2017

Event Type  Injury  

Event Description

On (b)(6) 2011, a 27 mm trifecta valve was implanted.On (b)(6) 2017, severe transvalvular insufficiency of the aortic valve bioprosthesis was noted.The valve was explanted and replaced with a 25 mm edwards perimount valve.The patient is reported to be recovering.Patient identifier and weight are protected under local privacy laws, and therefore are not recorded.

Manufacturer Narrative

An event of ¿severe transvalvular insufficiency of the aortic valve bioprosthesis¿ was reported.The results of this investigation concluded tears in the free edge and base of leaflet 1.There was circumferential fibrous pannus ingrowth on the inflow surface, which narrowed the inflow diameter.Pannus on the outflow surface was also noted on the sewing cuff.Leaflets 1 and 3 contained fibrous thickening.Leaflets 2 and 3 contained chronic inflammation within the pannus and leaflet 2 contained focal calcifications.No acute inflammation was noted on leaflet 1.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2011, a 27 mm trifecta valve was implanted.On (b)(6) 2017, severe transvalvular insufficiency of the aortic valve bioprothesis was noted.During explant, a 2mm tear was noted at the commissure between the left and right coronary cusps.The valve was explanted and replaced with a 25 mm edwards perimount valve.The patient is reported to be recovering.Patient identifier and weight are protected under local privacy laws, and therefore are not recorded.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7157054
• MDR Text Key: 96143968
• Report Number: 3008452825-2018-00001
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 01/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2013
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 3398001
• Other Device ID Number: 05414734052054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2010
• 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
• Patient Age: 62 YR