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

Model Number	H749LVSUS230
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Thrombosis (2100)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that aortic valve thrombosis occurred.Vascular access was obtained via a right transfemoral approach.A 23mm lotus edge valve was successfully implanted however, upon implant, a gradient of 28mm was noted.Upon removal of the 23mm lotus edge valve system, thrombus was noted throughout the implant.The clot was on the braid frame and the sheathing aids.There was no indication thrombus was present on the 23mm lotus edge valve prior to removal.No further treatment was administered for the thrombus as the patient had been heparinized and the patients act was above 300.The procedure was completed with the successful implant of a 25mm lotus edge valve.The patient has had no further issues.
Additional Manufacturer Narrative
H3: device eval by manufacturer: the lotus edge valve delivery system was received by bsc and analyzed by a bsc quality engineer.The device was returned in the sterilization bottle partially filled with saline.The bottle was removed.The valve was returned unsheathed.Visual examination of the valve found a blood like substance on buckle position 11.The substance was easily removed using a tweezers.The valve leaflets were examined and no issues or damage were noted to the tissue.No other issues were noted with the device or valve components.H6: patient codes: updated.H6: device codes: updated.
Event or Problem Description
It was reported that aortic valve thrombosis occurred.Vascular access was obtained via a right transfemoral approach.A 23mm lotus edge valve was successfully implanted however, upon implant, a gradient of 28mm was noted.Upon removal of the 23mm lotus edge valve system, thrombus was noted throughout the implant.The clot was on the braid frame and the sheathing aids.There was no indication thrombus was present on the 23mm lotus edge valve prior to removal.No further treatment was administered for the thrombus as the patient had been heparinized and the patients act was above 300.The procedure was completed with the successful implant of a 25mm lotus edge valve.The patient has had no further issues.

• 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: 10310927
• Report Number: 2134265-2020-09258
• Device Sequence Number: 19679257
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 07/05/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0024536781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention