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

Catalog Number TF-21A

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014 a 21mm trifecta valve (tf-21a, 180110465) was successfully implanted during aortic valve replacement surgery.On 10 may 2023, the patient presented to the emergency room with complaints of increasing dyspnea and bilateral lower extremity swelling.The patient was diagnosed with cardiomyopathy, congestive heart failure, severe stenosis and aortic valve disorder.The leaflets were observed to be opening minimally.The patient was admitted for treatment and was stabilized.On (b)(6) 2023, the patient underwent an aortic valve replacement surgery to replace the trifecta valve due to deterioration.A 23mm non-abbott device was implanted.The explanted trifecta valve was observed to have small adherent of tan/grey calcified tissue.The patient is reported to be alive and well.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the patient presented to the emergency room with increasing dyspnea and bilateral lower extremity swelling after nine years of implant.Also reported that the patient was diagnosed with cardiomyopathy, congestive heart failure, severe stenosis and aortic valve disorder.The leaflets were observed to be opening minimally.On (b)(6) 2023, the patient underwent an aortic valve replacement surgery to replace the trifecta valve due to deterioration.The explanted trifecta valve was reported to have small adherent of tan/grey calcified tissue.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, based on the information received, the reported event is consistent with structural valve deterioration (svd).A variety of factors may contribute to svd, including patient and biological factors: biological factors which can result in tissue degeneration such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.) or thinning of the prosthetic leaflet tissue (predisposing to leaflet tears) also could not be confirmed as the valve was not returned for histopathological examination.Stenosis was reported which could have been caused by pannus on the valve leaflets or calcification; both of which also can contribute to leaflet tears formation.Neither could be confirmed as the valve was not received for examination.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 18654900
• MDR Text Key: 334702737
• Report Number: 2135147-2024-00539
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)160121(10)4564023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2016
• Device Catalogue Number: TF-21A
• Device Lot Number: 4564023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2014
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 79 KG