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

Model Number	H749LVSUS250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Aortic Dissection (2491)
Date of Event	10/20/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that an aortic dissection and patient death occurred.The patient was selected for a 25mm lotus edge valve implant due to aortic stenosis.The patient had a tortuous descending aorta, mild stenosis, and moderate calcium in leaflets with none present at the native annulus.Predilatation was not performed.The 25mm lotus edge valve delivery system was advanced relatively easy.During deployment of the lotus edge valve, a dissection was observed in the ascending aorta.After release of the lotus edge valve, the dissection was no longer apparent and appeared to be sealed.The patient was stable and was sent to recovery.Two hours later the patient decompensated and passed away.The cause of the dissection and patient death is unknown.

• 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: 10817358
• Report Number: 2134265-2020-15325
• Device Sequence Number: 1926386
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/10/2020

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: 01/10/2021
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0026194719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death