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

Model Number	H749LVSUS230
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lotus edge valve delivery system kinked when inserted into the isleeve introducer.A 23mm lotus edge valve system was chosen for a transcatheter aortic valve replacement (tavr) procedure.Access was gained through a right transfemoral approach.During insertion of the delivery system into the isleeve introducer, a kink nearly the curvature on the delivery system catheter occurred.The procedure outcome was noted to be successful.The patient is alive and well.

• 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: 10416815
• Report Number: 2134265-2020-11214
• Device Sequence Number: 2386272
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/17/2020

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: 08/06/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0024705743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1