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

Model Number 10418

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

Patient Problems Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 12/08/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that hypo-attenuating leaflet thickening occurred.The patient was enrolled into the (b)(6) study in (b)(6) 2019 and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or other antiplatelet medications.A loading dose of 81 mg of aspirin was given the day of the procedure.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 27 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial and complete re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).Two days post index procedure, the patient was discharged on clopidogrel.In (b)(6) 2020, 390 days post index procedure, a computed tomography scan revealed hypo-attenuating leaflet thickening.No action was taken to treat the event.At the time of reporting, the event was considered recovering.

Event Description

Reprise iv study.It was reported that hypo-attenuating leaflet thickening occurred.The patient was enrolled into the reprise iv study in (b)(6) 2019 and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or other antiplatelet medications.A loading dose of 81 mg of aspirin was given the day of the procedure.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 27 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial and complete re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).Two days post index procedure, the patient was discharged on clopidogrel.In (b)(6) 2020, 390 days post index procedure, a computed tomography scan revealed hypo-attenuating leaflet thickening.No action was taken to treat the event.At the time of reporting, the event was considered recovering.It was further reported that 390 days post index procedure, a computed tomography scan was performed and revealed that the 27 mm lotus edge valve was well-seated in the aortic annulus.The scan revealed that the patient's leaflets were thin and pliable, except for the anterior-most leaflet, adjacent to the right coronary cusp, which had evidence of hypo-attenuating leaflet thickening.There was full closure coaptation and full systolic opening with was no evidence of structural valvular degeneration or paravalvular leak.The native cusps were well opacified with no root thrombus noted.There was a beam hardening artifact off the stent frame, especially adjacent to the supra-annular stent posts, mild fusiform aneurysm of the ascending aorta with a max dimension of 38mm, and severely dilated main pulmonary artery 38mm.A medication adjustment was made to treat the event.

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: 11108901
• MDR Text Key: 224798405
• Report Number: 2134265-2020-18683
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0024336108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR