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

Model Number	H749LVSUS270
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system kinked.A 27mm lotus edge valve was selected for implant.Upon insertion through the isleeve introducer sheath, the lotus edge valve delivery system exhibited resistance and then kinked in two locations along the catheter.The lotus edge valve delivery system was removed with resistance.A new lotus edge valve was inserted and successfully implanted.There were no reported patient consequences.

• 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: 10835662
• Report Number: 2134265-2020-15737
• Device Sequence Number: 17166157
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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: 01/21/2021
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0026021299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1