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

Catalog Number TF-19A

Device Problems Calcified (1077); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/16/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, a 19mm trifecta valve was implanted in an aortic valve replacement.The native valve dimension was 22mm.In (b)(6) 2022, progression of aortic stenosis became apparent with a valve pressure gradient of 40mmhg.In (b)(6) 2023, the patient had a valve pressure gradient of 40mmhg and worsening dyspnea, and the patient was urgently hospitalized due to signs of heart failure.On (b)(6) 2023, the 19mm trifecta valve was explanted.Visualization of the explanted valve exhibited pannus, calcification, and thrombus.Thrombus could not be confirmed via echocardiogram previously.A replacement 21mm epic supra valve was implanted.The patient was reported to be stable.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to aortic stenosis, worsening dyspnea and signs of heart failure was reported.Also reported was visualization of the explanted valve exhibited pannus, calcification, and thrombus.The investigation found calcifications on all three leaflets with immobilization/limited mobility of all leaflets.There was fibrous pannus ingrowth on outflow surface of leaflets 1 and 2.Thin layer of fibrin present on inflow surface of leaflets 1 and 2.Leaflet 3 was torn.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear in leaflet could not be conclusively determined; however, was associated with calcifications.The calcifications found would have contributed to the reported stenosis.

• 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: 18322141
• MDR Text Key: 330410711
• Report Number: 2135147-2023-05481
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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: 12/04/2015
• Device Catalogue Number: TF-19A
• Device Lot Number: 4555309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• 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; Hospitalization; Life Threatening
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 45 KG