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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2015

Event Type  Death  

Manufacturer Narrative

B2 - date of death is estimated.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title aortic regurgitation, time to aortic valve re-intervention, and mortality in degenerated trifecta versus non-trifecta bioprosthesis.

Event Description

The article, "aortic regurgitation, time to aortic valve re-intervention, and mortality in degenerated trifecta versus non-trifecta bioprosthesis", was reviewed.The article presented a retrospective, single center study in patients who underwent redo aortic valve replacement (redo-avr) with either valve in valve transcatheter aortic valve replacement (viv-tavr) or redo-surgical aortic valve replacement (redo-savr) for bioprosthetic structural valve deterioration (svd).Devices included medtronic mosaic, carpentier edwards perimount/perimount magna, st.Jude (abbott) epic, medtronic hancock ii, medtronic freestyle, sorin mitroflow, and st.Jude (abbott) trifecta.The article concluded that compared to non-trifecta valves, trifecta valves exhibit early svd primarily as ar and progress rapidly to significant svd requiring redo-avr.Mortality is significantly higher with trifecta compared to non-trifecta valves potentially impacting the results of savr versus tavr studies.[the primary and corresponding author was amr abbas, department of cardiovascular medicine, (b)(6) hospital, (b)(6), with corresponding email: (b)(6)].The time frame of the study was from 2015 to 2022.A total of 171 patients were included in the study, of which 73 received an abbott device (58 - trifecta, 15 - epic).The average age was 61 years and the majority gender was male.Comorbidities included tobacco use, hypertension, hyperlipidemia, diabetes mellitus, chronic kidney disease, and coronary artery disease.

Event Description

The article, "aortic regurgitation, time to aortic valve re-intervention, and mortality in degenerated trifecta versus non-trifecta bioprosthesis", was reviewed.The article presented a retrospective, single center study in patients who underwent redo aortic valve replacement (redo-avr) with either valve in valve transcatheter aortic valve replacement (viv-tavr) or redo-surgical aortic valve replacement (redo-savr) for bioprosthetic structural valve deterioration (svd).Devices included medtronic mosaic, carpentier edwards perimount/perimount magna, st.Jude (abbott) epic, medtronic hancock ii, medtronic freestyle, sorin mitroflow, and st.Jude (abbott) trifecta.The article concluded that compared to non-trifecta valves, trifecta valves exhibit early svd primarily as ar and progress rapidly to significant svd requiring redo-avr.Mortality is significantly higher with trifecta compared to non-trifecta valves potentially impacting the results of savr versus tavr studies.[the primary and corresponding author was amr abbas, department of cardiovascular medicine, william beaumont university hospital, corewell health east, royal oak, mi 48073, with corresponding email: amr.Abbas@corewellhealth.Org] the time frame of the study was from 2015 to 2022.A total of 171 patients were included in the study, of which 73 received an abbott device (58 - trifecta, 15 - epic).The average age was 61 years and the majority gender was male.Comorbidities included tobacco use, hypertension, hyperlipidemia, diabetes mellitus, chronic kidney disease, and coronary artery disease.

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.Literature attachment: article title "aortic regurgitation, time to aortic valve re-intervention, and mortality in degenerated trifecta versus non-trifecta bioprosthesis" the additional patient effects and malfunctions reported in the article are captured under separate medwatch reports.Summarized patient outcomes/complications of patients who underwent redo aortic valve replacement (redo-avr) with either valve in valve transcatheter aortic valve replacement (viv-tavr) or redo-surgical aortic valve replacement (redo-savr) for bioprosthetic structural valve deterioration (svd) were reported in a research article,"aortic regurgitation, time to aortic valve re-intervention, and mortality in degenerated trifecta versus non-trifecta bioprosthesis" in a subject population with multiple co-morbidities including tobacco use, hypertension, hyperlipidemia, diabetes mellitus, chronic kidney disease, and coronary artery disease.Some of the complications reported were death, surgical intervention (explant and valve-in-valve), hospitalization, aortic stenosis, aortic regurgitation; 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; however, based on medical review of qualitative inputs compared to non-trifecta valves, trifecta valves exhibit early svd primarily as ar and progress rapidly to significant svd requiring redo-avr.Mortality is significantly higher with trifecta compared to non-trifecta valves potentially impacting the results of savr versus tavr studies.While ar (aortic regurgitation) of any degree occurred significantly earlier in trifecta patients (3.1 years) compared to non-trifecta (10.8 years), it progressed to significant ar requiring redo-avr within 2 years from its onset in either group.

• 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: 19202706
• MDR Text Key: 341281768
• Report Number: 2135147-2024-01884
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/04/2024
• 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
• Patient Outcome(s): Death