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

Catalog Number TF-21A

Device Problem Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/01/2023

Event Type  Injury  

Event Description

The article, "treatment of heart failure caused by acute ar caused by svd a case of perforation of the pulmonary artery by a right heart catheter complicated by overuse of coil-embolization and ecmo driven inferior tavin sav", was reviewed.The article presented a case study of an 83-year-old woman with atrial flutter, dyslipidemia, and aortic stenosis.It was reported that on an unknown date, a 21mm trifecta valve was implanted.It was then reported nine years post-procedure, the patient presented with shortness of breath on exertion, and was admitted to the hospital for acute cardiac insufficiency.Noninvasive positive pressure ventilation and drug treatment were started, but the response was poor.Transthoracic cardiac ultrasonography revealed aortic regurgitation as cause of heart failure with suspected structural valve deterioration (svd) of the trifecta valve.A swan-ganglia catheter (sgc) was placed but the patient experienced cardiopulmonary arrest with suspected pulmonary artery perforation caused by sgc.After successful treatment of perforation via pulmonary artery coil embolization with target xl 8mm/30cm x 1 and 10mm/40cm x 3, venoarterial extracorporeal membrane oxygenation (va-ecmo) was performed.On the fifth day after rehospitalization, a transcatheter valve-in-valve procedure was performed with a 23mm evolut pro+.The patient status was reported stable and was transferred for rehabilitation on the 135th day.The article concluded pulmonary artery perforation due to sgc is a rare but fatal complication.On the other hand, there are many svd in trifecta valve at a relatively early stage after operation, and there are many reports of ar due to fissure of the valve lobe.They report a suggestive case of aortic valve therapy with concomitant pulmonary injury and svd with a review of the literature.[the primary author was seita kondo, showa university hospital, japan].

Manufacturer Narrative

As reported in a research article, treatment of heart failure caused by acute ar caused by svd a case of perforation of the pulmonary artery by a right heart catheter complicated by overuse of coil-embolization and ecmo driven inferior tavin sav, at an unknown date, a 21mm trifecta valve was implanted in an 83-year-old woman with atrial flutter, dyslipidemia, and aortic stenosis.Nine years post-procedure, the patient presented with shortness of breath on exertion, and was admitted to the hospital for acute cardiac insufficiency.Transthoracic cardiac ultrasonography revealed aortic regurgitation as cause of heart failure with suspected structural valve deterioration (svd).A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18149134
• MDR Text Key: 328288837
• Report Number: 2135147-2023-05053
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

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 Catalogue Number: TF-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 83 YR
• Patient Sex: Female