MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE; LOTUS EDGE TM VALVE SYSTEM 23 MM

Model Number	H749LVSUS230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that hypotension occurred.A lotus introducer sheath was placed in the right femoral artery and a 23mm lotus edge valve was advanced for implantation.Upon initial deployment, the patient became hypotensive and was given vasopressors.Partial re-sheathing was performed to reposition, in accordance with the directions for use.Once the lotus edge valve was placed and functioning, the hypotension resolved.The implant was successful and the lotus edge delivery system was removed.Upon removal of the lotus introducer sheath, the patient had a vasospasm.Medication was given to relax artery.The lotus introducer sheath was slowly removed from the vessel.An assessment shot was taken and it was seen that the external to common iliac was severely damaged.Covered stents were placed.Blood was given to the patient.A vascular surgeon was called in and the patient was transferred to the operating room.The patient died in the operating room.The death was not related to the lotus edge valve.

• Brand Name: LOTUS EDGE VALVE
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM 23 MM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9883501
• Report Number: 2134265-2020-03721
• Device Sequence Number: 2794670
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/26/2020

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: 07/06/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0024542987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR