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

Model Number	H749LVSUS230
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that hypotension, ventricular fibrillation, cardiac arrest and death occurred.The native aortic annulus was 24.2mm in diameter.The peripheral vessels were extremely calcified.A lotus introducer sheath was selected for use and would not advance due to the calcification.The procedure was continued without an access sheath.A 25mm lotus edge valve was advanced and had difficulty crossing the native aortic annulus.The 25mm lotus edge valve was removed and balloon aortic valvuloplasty was performed.The 25mm lotus edge valve was reinserted for implantation.Upon unsheathing, asymmetric appearance was noted.When the lotus edge valve was deployed and brought to lock, one of the posts would not lock.Additional maneuvers were tried to lock the post.During this time, the patient's blood pressure dropped.The 25mm lotus edge valve was removed.The patient had complications of ventricular fibrillation and cardiac arrest.Cardiopulmonary resuscitation was started.A 23mm lotus edge valve was advanced and implanted successfully.There was mild to moderate regurgitation noted post implant.The patient had been stabilized with a heart pump placed in the left axillary and was brought to the intensive care unit.One day post implant procedure, the heart pump access site began bleeding.Surgery was discussed to move the heart pump.The family opted not to continue care.The patient died that night.
Event or Problem Description
It was further reported that this device did not cause or contribute to the patient harms and death, however, there was mild to moderate prosthetic aortic valve regurgitation after implantation of the 23mm lotus edge valve.It was reported that hypotension, ventricular fibrillation, cardiac arrest and death occurred.The native aortic annulus was 24.2mm in diameter.The peripheral vessels were extremely calcified.A lotus introducer sheath was selected for use and would not advance due to the calcification.The procedure was continued without an access sheath.A 25mm lotus edge valve was advanced and had difficulty crossing the native aortic annulus.The 25mm lotus edge valve was removed and balloon aortic valvuloplasty was performed.The 25mm lotus edge valve was reinserted for implantation.Upon unsheathing, asymmetric appearance was noted.When the lotus edge valve was deployed and brought to lock, one of the posts would not lock.Additional maneuvers were tried to lock the post.During this time, the patient's blood pressure dropped.The 25mm lotus edge valve was removed.The patient had complications of ventricular fibrillation and cardiac arrest.Cardiopulmonary resuscitation was started.A 23mm lotus edge valve was advanced and implanted successfully.There was mild to moderate regurgitation noted post implant.The patient had been stabilized with a heart pump placed in the left axillary and was brought to the intensive care unit.One day post implant procedure, the heart pump access site began bleeding.Surgery was discussed to move the heart pump.The family opted not to continue care.The patient died that night.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.H1 - type of reportable event: updated.

• 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: 9878978
• Report Number: 2134265-2020-03604
• Device Sequence Number: 14307461
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 04/14/2020

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: 03/27/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0024008728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 47