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

Model Number TFGT-21A

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 07/20/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a bentall procedure was performed and a 21mm trifecta gt valve and a 24mm prosthetic graft (non-abbott) were implanted.On (b)(6) 2018, the trifecta valve and composite graft were explanted due to suspicion of infective endocarditis.Another bentall procedure was performed and a 23mm trifecta gt valve was implanted with a 26mm prosthetic graft (non-abbott).Per the physician, the cause of the infection is unknown.The sewing cuff was damaged during explant of the valve.

Manufacturer Narrative

The reported event of infective endocarditis was confirmed.Morphological and histopathological examination found vegetations on the inflow and outflow surfaces of all leaflets with acute and chronic inflammation.Gram stains were negative for organisms, consistent with treatment effect.Leaflets 1 and 2 contained microcalcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the endocarditis remains unknown.

• Brand Name: TRIFECTA¿ GT 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7779489
• MDR Text Key: 116994827
• Report Number: 3008452825-2018-00273
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029/S021
• 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: 09/07/2018

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: 08/29/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6139886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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: 68 YR
• Patient Weight: 50