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

Model Number	H749LVSUS230
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis (2100); Thrombosis/Thrombus (4440)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shortness of breath and valve thrombosis occurred.A 23mm lotus edge valve was successfully implanted.Aspirin and plavix were given post procedure.Twenty eight (28) days post procedure, the patient presented with shortness of breath.Echocardiography indicated an increase in gradient from 7mm hg to 46mmhg and confirmed valve thrombosis.Plavix was discontinued and eloquis 2.5 taken twice a day (bid) was prescribed.Patient will return for followup echocardiogram in two weeks.
Event or Problem Description
It was reported that shortness of breath and valve thrombosis occurred.A 23mm lotus edge valve was successfully implanted.Aspirin and plavix were given post procedure.Twenty eight (28) days post procedure, the patient presented with shortness of breath.Echocardiography indicated an increase in gradient from 7mm hg to 46mmhg and confirmed valve thrombosis.Plavix was discontinued and eloquis 2.5 taken twice a day (bid) was prescribed.Patient will return for followup echocardiogram in two weeks.It was further reported that post-procedure moderate aortic regurgitation occurred.
Additional Manufacturer Narrative
B5 describe event or problem - updated.B6 impact codes - updated.B6 device codes - updated.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10474519
• Report Number: 2134265-2020-11417
• Device Sequence Number: 11497904
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025020125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 02/26/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92630745-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention