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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problems Degraded (1153); Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Stroke/CVA (1770); Tachycardia (2095); Thrombocytopenia (4431); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/01/2015

Event Type  Death  

Event Description

The abstract article, ¿structural valve deterioration of trifecta valve: mechanism and management at a new zealand tertiary centre¿, was reviewed.The abstract article presented a retrospective single center study on the overall safety of the trifecta valve, the rates of failure, and management options of early trifecta failure.The devices in the study were trifecta and trifecta gt, or perimount magna ease valve (edwards, irvine, ca, usa).The abstract article concluded this review found an acceptable safety profile with the trifecta valve and demonstrated excellent hemodynamics, consistent with other studies.However, experience of early valve failures is concerning for valve durability.Transcatheter valve-in-valve is a suitable treatment option for early failure; however, further multicenter echocardiographic follow-up is required to characterize the mechanism of trifecta failures over time.[(b)(6)].The time frame of the study was from january 2015 to july 2019.A total number of 525 patients were included in this study, of which 226 received a trifecta valve and 37 received a trifecta gt valve.The average age was 72 years and the average gender was male.Comorbidities included hypertension, hyperlipidemia, cerebrovascular disease, smoking history, myocardial infarction, diabetes, severe renal impairment, aortic stenosis, aortic regurgitation, endocarditis, left ventricle ejection fraction.

Manufacturer Narrative

Literature article: structural valve deterioration of trifecta valve: mechanism and management at a new zealand tertiary centre.Summarized patient outcomes/complications of structural valve deterioration of trifecta valve: mechanism and management at a new zealand tertiary centre were reported in a research article in a subject population with no information on patient characteristics or comorbidities.Some of the complications reported were stroke, general structural valve deterioration, cusp tears, permanent pacemaker, redo surgical valve replacement procedure, transcatheter valve-in-valve procedure 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.

• 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: 17684801
• MDR Text Key: 322659813
• Report Number: 2135147-2023-03852
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 08/11/2023
• 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): Death