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

Model Number	H749LVSUS230
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to advance occurred.A 23mm lotus edge valve system, xs safari2 guidewire, and an isleeve were selected for a transcatheter aortic valve replacement(tavr) procedure.Access was gained through a left transfemoral approach.Pre-dilation was completed with a 16mm non-bsc balloon, according to the instructions for use(ifu).The 23mm lotus edge valve system was advanced but failed to cross the native valve.The physician attempted to cross the native valve with the 23mm lotus edge valve system multiple times without success.The 23mm lotus edge valve system was removed.A non-bsc valve system was inserted and also failed to cross the native valve.Wire position was lost.The physician recrossed the native valve with a.035 guidewire and positioned the wire into the ventricle.The non-bsc valve was then able to cross the native valve and was successfully implanted.No patient complications were reported.

• 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: 10427070
• Report Number: 2134265-2020-11196
• Device Sequence Number: 16864326
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025727075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Patient Age: 85 YR