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

Model Number	TF-27A
Medical Device Problem Codes	Backflow (1064); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	10/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2015, a 27mm trifecta valve was selected for implant in the patient's aortic position.On (b)(6) 2020, the valve was explanted after the patient presented with acute aortic regurgitation.Echocardiography showed severe trans - valvular aortic regurgitation.A replacement edwards perimount valve was implanted and the patient was reported to be stable and recovering.
Additional Manufacturer Narrative
Explant was reported due to regurgitation.The investigation found that leaflet 1 and 2 contained tears and folds causing incomplete coaptation.There was circumferential fibrous pannus ingrowth on the inflow surface of the valve which extended onto the bases of all three leaflets and narrowed the inflow diameter.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the tears could not be conclusively determined, however there were degenerative changes found to the tissue at the site of the tears, which could have contributed to the tear formation.The tears and folds causing incomplete coaptation would have contributed to the reported regurgitation.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: 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
• MDR Report Key: 9845102
• Report Number: 3008452825-2020-00130
• Device Sequence Number: 16334893
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 5153058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention