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

Model Number TF-21A

Device Problem Torn Material (3024)

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

Event Type  Injury  

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed and this 21 mm trifecta valve was implanted.In (b)(6) 2016, an echocardiogram revealed aortic regurgitation.The patient did not follow-up for any further visits until (b)(6) 2017.At this time, a perforation of a leaflet was observed via a repeated echocardiogram.On (b)(6) 2017, a re-do avr was performed and this valve was explanted and replaced with a 19mm on-x heart valve.Pannus formation was observed on this valve.No findings of infective endocarditis were noted.The information regarding the patient¿s weight and postoperative condition was not provided.No further information is expected.

Manufacturer Narrative

An event of ¿aortic regurgitation¿ was reported.Gross morphological and histopathological examination revealed a perforation in the mid portion leaflet 1.There were no inflammation or significant calcifications 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7106324
• MDR Text Key: 94466642
• Report Number: 3008452825-2017-00322
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2015
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4127368
• Other Device ID Number: 05414734052023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2013
• 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: 80 YR