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

Model Number	H749LVSUS270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Death (1802); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Stenosis (2263)
Date of Event	11/12/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced left bundle branch block (lbbb), vessel occlusion, ventricular fibrillation, hypotension, and death.The aortic valve was treated with deployment of the 27mm lotus edge valve.After deployment, the patient went into lbbb.The positioning was observed to be approximately 7mm deep, so the physician decided to reposition higher.Successful repositioning of the lotus edge valve involved re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).The patient's rhythm returned to a normal sinus rhythm and the physician's were satisfied with the valve positioning.After the lotus edge valve was released, the patient's left coronary system shut down, as seen via angiography.The patient experienced hypotension and cardiac rhythm changes.Two coronary stents were placed; however, the patient had several rounds of ventricular fibrillation.Chest compressions were started and went for 45 minutes.The patient was stabilized and transferred to the intensive care unit, where later, passed away.

• 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: 10945195
• Report Number: 2134265-2020-16809
• Device Sequence Number: 19597213
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: 12/08/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0026029026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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; Required Intervention