MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	TF-21A
Medical Device Problem Codes	Degraded (1153); Patient-Device Incompatibility (2682); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2018, a 21mm trifecta valve was implanted for aortic valve repair (avr) procedure with a concomitant coronary artery bypass graft (cabg) procedure.It was reported that the patient was hospitalized on (b)(6) 2023 for chest pain, breathlessness, loss of appetite, and cough with sputum due to early structural valve deterioration.It was reported on an unknown date in (b)(6) 2023, the patient underwent redo surgical aortic valve replacement procedure.
Additional Manufacturer Narrative
An event of structural valve deterioration, fibrotic thickening of the leaflet, central regurgitation, angina, and dyspnea was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Reportedly, a 21 mm trifecta valve was implanted for aortic valve repair (avr) procedure with a concomitant coronary artery bypass graft (cabg) procedure in 2018.In 2023, the patient was hospitalized for chest pain, breathlessness, loss of appetite, and cough with sputum due to early structural valve deterioration.Later on, the patient underwent consultation for a planned redo intervention.In 2024, a 2d transesophageal echocardiography (tee) noted severe valvular aortic regurgitation due to thickened leaflets with mean and peak gradient of 32mmhg and 50mmhg, respectively.The patient also had a dilated left atrium with mild concentric left ventricular hypertrophy (lvh), no left ventricular regional wall motion abnormalities (rwma) with left ventricular ejection fraction (lvef) of 55%.No left coronary, vegetation, or pulmonary embolism was confirmed.Based on the available information, the cause of the reported incident could not be conclusively determined.There is no indication of a product issue with regards to manufacture, design, or labeling.Corrections h6 health effect - impact code: code 4624 removed.H6 medical device problem code: code 1153 removed.
Event or Problem Description
It was reported that on (b)(6) 2018, a 21mm trifecta valve was implanted for aortic valve repair (avr) procedure with a concomitant coronary artery bypass graft (cabg) procedure.It was reported that the patient was hospitalized on (b)(6) 2023 for chest pain, breathlessness, loss of appetite, and cough with sputum due to early structural valve deterioration.It was reported on an unknown date in (b)(6) 2023, the patient underwent consultation for a planned redo intervention.During a follow-up consultation on 10 (b)(6) 2024, a 2d transesophageal echocardiography (tee) noted severe valvular aortic regurgitation due to thickened leaflets with mean and peak gradient of 32mmhg and 50mmhg, respectively.The patient also had a dilated left atrium with mild concentric left ventricular hypertrophy (lvh), no left ventricular regional wall motion abnormalities (rwma) with left ventricular ejection fraction (lvef) of 55%.No left coronary, vegetation, or pulmonary embolism was confirmed.No intervention was reported for the valve.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18413487
• Report Number: 2135147-2023-05775
• Device Sequence Number: 15634275
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)191129(10)BR00014901
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2019
• Device Catalogue Number: TF-21A
• Device Lot Number: BR00014901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male