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 Codes	Arrhythmia (1721); Complete Heart Block (2627)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right bundle branch block(rbbb) and complete heart block (chb) occurred.A 25mm lotus edge valve system was selected for a transcatheter aortic valve replacement (tavr) procedure.Access was gained from a right transfemoral approach.During the procedure the patient developed rbbb.Post procedure the patient developed chb and was implanted with a permanent pacemaker to treat the event.The patient was discharged home and is doing fine.

• 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: 10530666
• Report Number: 2134265-2020-12288
• Device Sequence Number: 2902579
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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: 10/29/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025108511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR