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

Catalog Number UNK TRIFECTA GT VALVE

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Cognitive Changes (2551)

Event Date 01/01/2017

Event Type  Injury  

Event Description

The article, "surgical aortic valve replacement in octogenarians: single-center perioperative outcomes and 5-years survival", was reviewed.The article presented a retrospective, single center study to evaluate perioperative outcome and long-term survival after surgical aortic valve replacement (savr) in octogenarians, comparing patients with low surgical risk.Devices included in this study were edwards perimount, magna ease, sorin crown, abbott trifecta gt, edwards intuity elite, livanova perceval/perceval plus.The article concluded that savr in patients =80yo is associated with low in-hospital mortality, although a significant proportion of patients develop complications.Long-term follow-up up to 5 years after surgery is acceptable in octogenarians with low surgical risk.[the primary and corresponding author was tiago velho, cardiothoracic surgery department, (b)(6) hospital, (b)(6) portugal, with corresponding email: (b)(6)] the time frame of the study was from january 2017 to january 2021.A total of 195 patients were included in this study, of which 12 (6.2%) received an abbott device.The average age was 82 years and the gender majority was male.Comorbidities included hypertension, diabetes mellitus, dyslipidemia, chronic kidney disease, peripheral vascular disease, cerebrovascular disease, chronic lung disease, ischemic cardiopathy, atrial fibrillation.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: TRIFECTA¿ GT 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: 18944473
• MDR Text Key: 338186260
• Report Number: 2135147-2024-01254
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TRIFECTA GT VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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): Required Intervention; Life Threatening; Disability