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 Code	Thrombosis (2100)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 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.One month after the 25mm lotus edge valve implant, the patient was brought in for a follow-up appointment.A computed tomography(ct) scan was performed and the radiologist described the hypo-attenuating leaflet thickening and noted valve thrombosis was present.Gradient had increased from 5mm one day post implant to 19mm.The patient was put on coumadin and will be seen in 30 days.
Event or Problem Description
It was reported that 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.One month after the 25mm lotus edge valve implant, the patient was brought in for a follow-up appointment.A computed tomography(ct) scan was performed and the radiologist described the hypo-attenuating leaflet thickening and noted valve thrombosis was present.Gradient had increased from 5mm one day post implant to 19mm.The patient was put on coumadin and will be seen in 30 days.It was further reported that the 23mm lotus edge valve was incorrectly attributed to this patient.The event of braid frame clot / thrombusduring the index procedure is not related to this procedure.The 25mm lotus edge valve was successfully implanted.
Additional Manufacturer Narrative
B5: describe event or problem: corrected.

• 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: 10513648
• Report Number: 2134265-2020-12152
• Device Sequence Number: 3538712
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/14/2020

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: 10/12/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025020146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR