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

Catalog Number TF-19A

Device Problems Off-Label Use (1494); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 06/01/2019

Event Type  Injury  

Event Description

User facility medwatch report was received that states "the patient underwent a 19mm trifecta pulmonary valve replacement on (b)(6) 2015 for tetralogy of fallat.In (b)(6) 2019 the patient developed severe pulmonary stenosis and insufficiency requiring a balloon valvuloplasty.Then in (b)(6) 2021 the patient re-developed pulmonary stenosis requiring another balloon valvuloplasty.In (b)(6) 2023 the patient had to undergo a third balloon valvuloplasty for redevelopment of pulmonary stenosis.During the valvuloplasty it was noted that the heart valve was at 17mm.The patient does have severe insufficiency with fixed leaflets of her bioprosthetic valve.Her valve true id is 17mm and cannot be expanded or fractured.The patient now has severe pulmonary insufficiency dilated right ventricle and exercise intolerance.The team has discussed her case and the next intervention will need to be surgical valve replacement due to the size constraints of the valve." it was reported that on (b)(6) 2015 a 19mm trifecta valve was implanted in a patient due to pulmonary valve tetralogy of follat.In (b)(6) 2019 the patient developed severe pulmonary stenosis and insufficiency requiring a balloon valvuloplasty.Than in (b)(6) 2021 tho patient re-developed pulmonary stenosis requiring another balloon valvuloplasty.In (b)(6) 2023 the patient had to undergo a third balloon valvuloplasty for redevelopment of pulmonary stenosis.Outing the valvuloplasty it was noted that the heart valve was true identify was at 17mm.The patient does have severe insufficiency with fixed leaflets of her bioprosthetic valve.Her valve true id is 17mm and cannot be expanded or fractured.The patient now has severe pulmonary insufficiency, dilated right ventricle, and exercise intolerance.The team has discussed her case and the next intervention will need to be surgical valve replacement due to the size constraints of the valve.

Manufacturer Narrative

B3 - date of event is estimated.An event of severe pulmonary stenosis and insufficiency requiring a balloon valvuloplasty after over 3 years of implant was reported.It was reported that the patient had to undergo a third balloon valvuloplasty for redevelopment of pulmonary stenosis.Field indicated that the next intervention will need to be surgical valve replacement due to the size constraints of the valve.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Please note that per the instructions for use,"valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction.Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues.Do not oversize the valve.If the native annulus measurement falls between two trifecta¿ valve sizes, use the smaller valve size.Use only the model tf2000 sizer set for sizing a trifecta¿ valve.".

• 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: 18314885
• MDR Text Key: 330327141
• Report Number: 2135147-2023-05469
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Catalogue Number: TF-19A
• Device Lot Number: 5002543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2015
• 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