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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problems Calcified (1077); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1981

Event Type  malfunction  

Event Description

The article, "mitral valve replacement in children: balancing durability and risk with mechanical and bioprosthetic valves", was reviewed.The article presented a retrospective, single center study to investigate if there is still a place for bioprosthetic mitral valve replacement in children by comparing the prosthetic durability and transplant-free survival after bioprosthetic and mechanical mitral valve replacement.Devices included in this study were ionescu shiley, carpentier-edwards, biocor/epic, trifecta, melody, crown prt, sapient xt, mosaic, inspiris resilia, bicarbon, carbomedics, st.Jude mechanical valve, and on-x.The article concluded that there is no difference in transplant-free survival after bioprosthetic and mechanical mitral valve replacement in children.The lifespan of bioprosthetic mitral valves remains limited in children because of structural valve failure due to calcification.44 after 15 years, 40% of mechanical valves were replaced, primarily because of patient-prosthesis mismatch related to somatic growth.[the primary and corresponding author was joeri van puyvelde, university hospitals leuven, cardiac surgery, herestraat 49, 3000 leuven, belgium, with corresponding email: joeri.Vanpuyvelde@uzleuven.Be].The time frame of the study was from january 1981 to december 2020.A total of 56 patients were included in this study.Of the 28 receiving a bioprosthetic valve, 13 (46.4%) received an abbott device.Of the 28 receiving a mechanical valve, 23 (82.1%) received an abbott device.For patients who received a bioprosthetic valve, the average age was 3.6 years, the average weight was 12.1 kg, and the majority gender was male.For patients who received a mechanical valve, the average age was 3.0 years, the average weight was 13.5 kg, and the majority gender was male.Comorbidities included atrioventricular canal defect, mitral regurgitation, mitral stenosis, endocarditis, prior mitral valve repair/replacement procedure.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects reported in the article are captured under separate medwatch reports.Literature attachment: article title: "mitral valve replacement in children: balancing durability and risk with mechanical and bioprosthetic valves".

Manufacturer Narrative

Summarized patient outcomes/complications of mitral valve replacement in children: balancing durability and risk with mechanical and bioprosthetic valves were reported in a research article in a subject population with multiple co-morbidities including atrioventricular canal defect, mitral regurgitation, mitral stenosis, endocarditis, prior mitral valve repair/replacement procedure.Some of the complications reported were surgical intervention, hospitalization, calcification, stenosis, regurgitation, post-dilation with balloon aortic valvuloplasty these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.The additional unk epic stented porcine hv and unk mechanical heart valve devices referenced in b5 are filed under separate medwatch report numbers.The additional patient effects reported in the article are captured under separate medwatch report.Literature attachment: article title " mitral valve replacement in children: balancing durability and risk with mechanical and bioprosthetic valves".

• 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: 19013609
• MDR Text Key: 339258788
• Report Number: 2135147-2024-01422
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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