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	Arrhythmia (1721); Death (1802); Aortic Dissection (2491); Vascular Dissection (3160)
Date of Event	08/24/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that an aortic dissection and death occurred.The patient was a frail high risk patient with dilated horizontal aorta and extremely tortuous anatomy.A 25mm lotus edge valve was selected for a transcatheter aortic valve replacement (tavr) procedure.The first positioning of the lotus edge valve was high and resulted in the valve popping out of the non-coronary cusp (ncc).The implanting team repositioned and the lotus edge valve was implanted with what looked like a great result.There was no obvious sign of aortic dissection on echocardiogram (echo) or angiography.The patient left the procedure in stable condition.The following morning, aortic dissection was confirmed via echo.No treatment was able to be provided and the patient died the same morning.The cause of death was aortic dissection.
Additional Manufacturer Narrative
B5 describe event or problem - updated.
Event or Problem Description
It was reported that an aortic dissection and death occurred.The patient was a frail high risk patient with dilated horizontal aorta and extremely tortuous anatomy.A 25mm lotus edge valve was selected for a transcatheter aortic valve replacement (tavr) procedure.The first positioning of the lotus edge valve was high and resulted in the valve popping out of the non-coronary cusp (ncc).The implanting team repositioned and the lotus edge valve was implanted with what looked like a great result.There was no obvious sign of aortic dissection on echocardiogram (echo) or angiography.The patient left the procedure in stable condition.The following morning, aortic dissection was confirmed via echo.No treatment was able to be provided and the patient died the same morning.The cause of death was aortic dissection.It was further reported that the patient also experienced an arrhythmia post procedure.

• 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: 10536462
• Report Number: 2134265-2020-12569
• Device Sequence Number: 1178086
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 09/03/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0024855506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 02/26/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92630745-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death