MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM

Model Number 10394

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

Patient Problems Aortic Insufficiency (1715); Dyspnea (1816); Thrombosis (2100)

Event Date 12/04/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced dyspnea and valve thrombosis.Vascular access was obtained via a transfemoral approach.The patient had a bicuspid aortic valve and a moderately tortuous anatomy.Pre-dilation was performed using a 20mm balloon.The 23mm lotus edge valve was advanced into position and the valve was deployed without difficulty.During the 6 month patient follow up visit, an aortic gradient of 78 mmhg was found suspecting valve thrombosis.From transesophageal echocardiogram (tee) images the leaflets appeared to be hypomobile.The patient did not receive additional treatment.The patient's condition is stable with dyspnea.

Event Description

It was reported that the patient experienced dyspnea and valve thrombosis.Vascular access was obtained via a transfemoral approach.The patient had a bicuspid aortic valve and a moderately tortuous anatomy.Pre-dilation was performed using a 20mm balloon.The 23mm lotus edge valve was advanced into position and the valve was deployed without difficulty.During the 6 month patient follow up visit, an aortic gradient of 78 mmhg was found suspecting valve thrombosis.From transesophageal echocardiogram (tee) images the leaflets appeared to be hypomobile.The patient did not receive additional treatment.The patient's condition is stable with dyspnea.It was further reported that the patient began antiplatelet therapy for the suspected valve thrombosis and will have another follow-up 3 months from (b)(6) 2020.

Manufacturer Narrative

B5 describe event or problem - updated.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10988390
• MDR Text Key: 220902298
• Report Number: 2134265-2020-17303
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P180029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: 10394
• Device Catalogue Number: 10394
• Device Lot Number: 0024703685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other