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

Catalog Number TF-21A

Device Problems Degraded (1153); Patient-Device Incompatibility (2682); Central Regurgitation (4068)

Patient Problems Angina (1710); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 331579372
• Report Number: 2135147-2023-05775
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)191129(10)BR00014901
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• 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: 70 YR
• Patient Sex: Male