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 Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Transient Ischemic Attack (2109)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of malfunction reported in the article is captured under a separate medwatch report.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "minimally invasive surgical aortic valve replacement versus transfemoral transcatheter aortic valve implantation in low-risk octogenarians", was reviewed.The article presented a retrospective, single center study on low-risk (society of thoracic surgeons [sts] score<4%) octogenarians before and after transfemoral transcatheter aortic valve implantation (tf-tavi) and minimally invasive aortic valve replacement (mini-avr) performed between (b)(6) 2013 and (b)(6) 2019; follow-up was completed in (b)(6) 2022.Devices included in this study were sapien 3/xt, evolut r, portico, trifecta, enable, perceval, intuity, and other unknown.The article concluded that in the present study on low-risk octogenarians, transfemoral tavi and minimally invasive avr showed comparable short-term and mid-term results.Both procedures are deemed safe and effective.Larger randomized controlled trials will be required to determine which low risk patients will benefit most from tavi.[(b)(6)].The time frame of the study was from (b)(6) 2013 to (b)(6) 2019.A total of 301 patients were included in this study, of which 20 received an abbott device.The average age was 83.8 years and the average gender was female.Comorbidities included arterial hypertension, diabetes mellitus, coronary artery disease, prior myocardial infarction, peripheral vascular disease, syncope, atrial fibrillation, pulmonary hypertension, chronic pulmonary disease, prior stroke, prior transient ischemic attack, and tumor.

Manufacturer Narrative

Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including arterial hypertension, diabetes mellitus, coronary artery disease, prior myocardial infarction, peripheral vascular disease, syncope, atrial fibrillation, pulmonary hypertension, chronic pulmonary disease, prior stroke, prior transient ischemic attack, and tumor.Some of the complications reported were acute kidney injury, new onset atrial fibrillation, permanent pacemaker implant, stroke, transient ischemic attack, bleeding, and paravalvular leak.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.Literature attachment: article title " minimally invasive surgical aortic valve replacement versus transfemoral transcatheter aortic valve implantation in low-risk octogenarians".

• 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: 18519577
• MDR Text Key: 332974640
• Report Number: 2135147-2024-00255
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 01/22/2024
• 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): Disability; Required Intervention; Life Threatening