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

Model Number TF-A

Device Problems Calcified (1077); Incomplete Coaptation (2507); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Literature attachment: transseptal snaring technique as a bailout from valvuloplasty balloon entrapment within a self-expanding valve: a case report.As reported in a research article, about 4.5 ears after a trifecta valve was implanted it was replaced with a transcatheter valve.It was indicated that stenosis and severe calcification was found.Complications included systolic heart murmur, leaflet incomplete coaptation, surgical intervention and hospitalization.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, however if the calcifications reported were present on the valve it could have contributed to the reported stenosis.

Event Description

The article, "transseptal snaring technique as a bailout from valvuloplasty balloon entrapment within a self-expanding valve: a case report", was reviewed.The article presents a case study of a 71-year-old man with severe aortic stenosis due to surgical aortic valve failure.It was reported that on an unknown date six years prior, the patient underwent surgical aortic valve replacement (savr) procedure with an unknown bioprosthetic valve.One year later, the patient presented to the hospital due to endocarditis and a decision was made to perform a second savr and explant the unknown valve.A 23mm trifecta valve was successfully implanted and it was confirmed all leaflets demonstrated good mobility.It was reported the patient had minor residual aortic pressure gradient nine days post procedure.It was reported that 54 months post-procedure, the patient was diagnosed with stenosis of the trifecta valve and presented with systolic heart murmur and moderate aortic gradient of 40mmhg.A decision was made to perform a transcatheter valve-in-valve procedure with a 26mm non-abbott transcatheter heart valve (thv) that was implanted successfully.It was reported post-procedure the next day, transthoracic echocardiography (tte) showed high residual gradient in the thv and computed tomography (ct) revealed underexpansion of the thv due to an immobile right coronary leaflet of the trifecta valve caused by severe calcification.A decision was made to perform an urgent balloon aortic valvuloplasty (bav) due to patient experiencing congestive heart failure and pulmonary edema.After bav procedure, it was noted the balloon had become entrapped within the thv.The balloon was removed successfully via transcatheter snare.The article concluded that transseptal snaring technique is a promising bailout strategy as an alternative to open-heart surgery for aortic valvuloplasty balloon entrapment.[the primary and corresponding author is yoichi sugiyama, department of cardiology, heart and lung center, helsinki university and helsinki university central hospital, haartmaninkatu 4, 00290 helsinki, finland, with corresponding email: cedar41@hotmail.Co.Jp].

• 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: 17196276
• MDR Text Key: 317812030
• Report Number: 2135147-2023-02737
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• 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: 71 YR
• Patient Sex: Male