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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

Event Description

The article, ¿a case series of novel technique of coronary protection for patients with low coronary height undergoing transcatheter aortic valve implantation¿, was reviewed.The article presented a retrospective single center study on a novel and simple strategy for protecting coronary arteries using simultaneous kissing balloon (skb) inflation during transcatheter aortic valve implantation (tavi).Devices included in this study were crown prt, perimount magna, trifecta, and sapien ultra s3.The article concluded simultaneous kissing balloon is a novel technique of coronary protection in patients undergoing tavi at high risk of coronary artery occlusion (cao).Further studies are required to establish the safety of this novel technique.[the primary and corresponding author was mohammad alkhalil, cardiothoracic centre, (b)(6) hospital, newcastle-upon-tyne ne7 7dn, united kingdom, with corresponding email: (b)(6).

Manufacturer Narrative

Summarized patient outcomes/complications of a case series of novel technique of coronary protection for patients with low coronary height undergoing transcatheter aortic valve implantation were reported in a research article in a subject population with multiple co-morbidities including hypertension, diabetes, chronic kidney disease, prior cardiac surgery, coronary artery disease, atrial fibrillation, aortic stenosis.Some of the complications reported were surgical intervention, hospitalization, stroke, general structural deterioration 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: 17671472
• MDR Text Key: 322520884
• Report Number: 2135147-2023-03838
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• 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: 08/25/2023
• 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