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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Inflammation (1932); Myocardial Infarction (1969); Cardiac Tamponade (2226); Coma (2417); Heart Block (4444)

Event Date 01/01/2010

Event Type  Injury  

Event Description

The article, "procedural selection strategy and clinical outcomes in mitral valve surgery with concomitant aortic valve replacement in elderly patients", was reviewed.The article presented a retrospective, single center study that investigated valve durability and survival using surgical strategy for mitral valve disease with concomitant surgical aortic valve replacement (savr) in elderly patients.Devices included in this study were magna ease, trifecta, mitroflow, mosaic, epic, physio ii, and memo 3d.The article concluded in double-valve surgery for elderly high-risk patients, appropriate selection of the mitral valve procedure with concomitant savr provided better early and long-term survival and valve durability.This surgical strategy may be beneficial in elderly patients with combined aortic and mitral valve disease.[the primary and corresponding author was kazuma handa, department of cardiovascular surgery, sakurabashi watanabe hospital, 2-4-32 umeda, kita-ku, osaka 530-0001, japan, with corresponding email: kazumahanda1116@gmail.Com].

Manufacturer Narrative

B3 - date of event is estimated.Summarized patient outcomes/complications of surgical valve implants were reported in a research article in a subject population with multiple co-morbidities.Some of the complications reported were bleeding, stroke, coma, dialysis, myocardial infarction, complete atrioventricular block, tamponade, gastrointestinal event, mediastinitis, endocarditis, surgical intervention, structural valve deterioration and hospitalization.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 root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.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: 18282936
• MDR Text Key: 329943763
• Report Number: 2135147-2023-05352
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• 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: 11/13/2023
• 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): Disability; Hospitalization; Required Intervention; Life Threatening