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 Endocarditis (1834); Hemorrhage/Bleeding (1888); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 01/01/2003

Event Type  Injury  

Manufacturer Narrative

Literature article: bovine pericardial versus porcine bioprosthetic aortic valves: a nationwide population-based cohort study in korea.D4 - the udi number is not known as the part and lot numbers were not provided.Summarized patient outcomes/complications comparing bovine with porcine valve replacement outcomes were reported in a research article.Some of the complications reported were endocarditis, reoperation, thromboembolism, hemorrhage, 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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, "bovine pericardial versus porcine bioprosthetic aortic valves: a nationwide population-based cohort study in korea", was reviewed.The article presented a retrospective, multicenter study to compare the clinical outcomes of aortic valve replacement using bovine pericardial and porcine bioprostheses, utilizing a nationwide administrative claims database.Devices included in this study were hancock ii valve, mosaic valve, sjm epic valve, sjm epic supra valve, sjm bicor porcine valve, toronto spv valve, soprano pericardial heart valve, carpentier edwards perimount magna tfx valve, carpentier edwards perimount valve, pericarbon more pericardial heart valve, avalus bioprosthesis, trifecta valve, mitroflow aortic pericardial heart valve/crown prt aortic heart valve, intuity elite valve system, and perceval s.The article concluded in this large nationwide cohort study of patients undergoing bioprosthetic aortic valve replacement utilization of porcine prostheses was significantly associated with an increased risk of reoperation than that of bovine prostheses, supporting previous findings.[the primary and corresponding author was joon bum kim, department of thoracic and cardiovascular surgery, asan medical center, university of ulsan college of medicine, olympic-ro 43-gil, songpa-gu, 20 seoul, 05505, republic of korea, with corresponding email: jbkim1975@amc.Seoul.Kr] the time frame of the study was from january 2003 to december 2018.A total of 7715 patients were included in this study, though it could not be confirmed how many received an abbott device.The average age was 72.1 years for patients given a bovine valve, and 72.2 years for patients given a porcine valve.The average gender was male.Comorbidities included hypertension, diabetes mellitus, dyslipidemia, atrial fibrillation, chronic kidney disease, dialysis, stroke, transient ischemic attack, systemic embolism, ischemic heart disease, myocardial infarction, prior percutaneous coronary intervention, congestive heart failure, anemia, chronic pulmonary obstructive disease, asthma, peripheral vascular disease, prior cardiac surgery, prior cancer, aortic stenosis, aortic regurgitation, smoking, alcohol use.

• 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: 18232137
• MDR Text Key: 329315604
• Report Number: 2135147-2023-05242
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 11/04/2023
• 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): Required Intervention; Hospitalization