MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A

Device Problem Backflow (1064)

Patient Problems Renal Failure (2041); Low Cardiac Output (2501); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "successful transcatheter aortic valve in valve implantation for degenerated trifecta bioprosthesis in a patient with a coronary anomaly", was reviewed.This research article presents a case study on a (b)(6) woman who was admitted to the hospital with acute heart failure.The patient underwent surgical aortic valve repair(savr) using a 23mm trifecta bioprosthesis for severe aortic stenosis due to a bicuspid aortic valve(bav) 6 years previously.On admission, echocardiography revealed severe aortic regurgitation and an ejection fraction of 57%.Computed tomography (ct) showed an anomalous origin of the right coronary artery (rca) from the left coronary sinus, with an interarterial course.The patient had shock vital and acute renal failure because of low cardiac output syndrome.Repeating savr was deemed too high risk, therefore, it was decided to perform an emergency transcatheter aortic valve in valve implantation(tavr-viv).Under general anesthesia with transesophageal echocardiography, a 26mm medtronic corevalve evolut r was implanted.The postoperative course was uneventful.The article concluded that although the patient had a high risk of coronary obstruction because of the use of stented bioprosthesis with externally mounted leaflets and short vtc, meticulous pre-procedural simulation and planning have led to the best procedural outcomes.To the best of our knowledge, this is the first report of a successful tavr-viv for stented bioprosthesis with externally mounted leaflets in a patient with a coronary artery.The primary and corresponding author of the article is akiko yamagata, department of cardiovascular surgery, tokyo women¿s medical university hospital, 8-1 kawada-cho, shinjuku-ku, tokyo 162-8666, japan with the corresponding email: akiko.Yamagata.716@gmail.Com.

Manufacturer Narrative

Additional information for:g3, g6, h2, h6, and h10 as reported in a research article, a patient implanted with a trifecta valve had heart failure and aortic regurgitation six years after implant so the valve was replaced with a valve-in-valve.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): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 11829036
• MDR Text Key: 255608375
• Report Number: 3008452825-2021-00280
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-23A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR