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

Model Number	H749LVSUS270
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that hypotension and heart block occurred.Procedure summary: the patient was selected for a 27mm lotus edge valve implant due to aortic stenosis.A right transfemoral access site was gained.The native aortic annulus and left ventricle outflow tract (lvot) were highly calcified.The native aortic valve was suspected to be a bicuspid valve with an extremely horizontal aortic arch.During deployment of the lotus edge valve, asymmetric unsheathing of the valve occurred multiple times.The patient experienced hypotension.The lotus edge valve was then removed and replaced with another manufacturer's valve.Electrocardiogram (ekg) changes were noted and heart block developed during the lotus edge valve deployment attempts.The heart block did not resolve and the patient received a permanent pacemaker.The patient was still recovering at the time of reporting.

• 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: 10878495
• Report Number: 2134265-2020-15904
• Device Sequence Number: 3766414
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: 11/06/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025922201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/20/2020
• 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
• Patient Age: 76 YR