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	Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/22/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that hypotension, pericardial perfusion, a perforation and death occurred.Procedure summary: a 27mm lotus edge valve system (lot: 0025743067) was selected for a transcatheter aortic valve replacement (tavr) procedure.During insertion, the lotus edge valve delivery system kinked as it was advanced over the transverse aortic arch.The lotus edge valve system was removed from the patient and a second 27mm lotus edge valve system (lot:0025743062) was inserted through the same introducer sheath over a safari2 guidewire.After crossing the native aortic annulus, stage one of valve deployment was positioned too high so a partial recapture was performed in accordance with the instructions for use (ifu).The second positioning attempt resulted in the valve being slightly distal, so the lotus edge valve was recaptured, repositioned and then released.During removal of the lotus edge valve delivery system as the device was coming around the aortic arch there was a significant drop in blood pressure.A pericardial effusion was noted and a pericardiocentesis was performed.The chest cavity was opened.It was observed the nosecone of the lotus edge delivery system had perforated the apex of the left ventricle with a 5mm hole.A kink was noted on the safari2 guidewire however the lotus edge valve delivery system moved freely on the guidewire.The patient died on the operating table.

• 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: 10841627
• Report Number: 2134265-2020-15169
• Device Sequence Number: 17076816
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/15/2020

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: 10/28/2020
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025743062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 86 YR