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

Catalog Number TF-23A

Device Problems Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/30/2023

Event Type  Injury  

Event Description

The article, "cardio-obstetrics team-based management of a pregnant patient with severe bioprosthetic aortic valve disease", was reviewed.The article presented a case study of a 38-year-old pregnant female patient with a bicuspid aortic valve.It was reported that on an unknown date, a 23mm trifecta valve was implanted.The patient presented 4 years post-procedure with swelling and dyspnea due to mild aortic stenosis, mean gradient = 22mmhg, noted by transthoracic echocardiography (tte).A year following, the patient was diagnosed with first-trimester pregnancy and tte noted the mean aortic gradient increased to 33mmhg and then 46mmhg when the patient was referred to a cardio-obstetrics program.During the patient's second trimester, the patient began experiencing mild heart failure that was managed via low-dose oral furosemide.A follow up tte noted the mean aortic gradient was 67mmhg and was diagnosed with moderate-to-severe aortic regurgitation.Early in the third trimester, the patient had worsening lower extremity edema leading to increase in furosemide.At 30 weeks' gestation, the patient was admitted for worsening heart failure and shortness of breath.Initially, the patient was diuresed with intravenous furosemide but had worsening symptoms that were not responding to furosemide.A decision was made to perform urgent transcatheter valve-in-valve (viv) procedure for severe aortic regurgitation.A 26mm medtronic corevalve evolut was implanted in a successful viv procedure with no complications and the patient was discharged home.The article concluded a valve and cardio-obstetrics team evaluation led to valve-in-valve transcatheter aortic valve replacement at 30 weeks¿ gestation.[the primary and corresponding author was retu saxena, abbott northwestern hospital-minneapolis heart institute, 800 east 28th street, suite 300, minneapolis, minnesota 55407, usa.E-mail: retu.Saxena@allina.Com].

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled ¿ cardio-obstetrics team-based management of a pregnant patient with severe bioprosthetic aortic valve disease".

Manufacturer Narrative

As reported in a research article, cardio-obstetrics team-based management of a pregnant patient with severe bioprosthetic aortic valve disease.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.From cine review: sequential doppler velocity imaging studies of the trifecta valve in the aortic position demonstrate evidence of an elevated transvalvular gradient consistent with a fibrous-calcification svd.Na.

• 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: 18608988
• MDR Text Key: 334142086
• Report Number: 2135147-2024-00414
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female