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

Model Number	H749LVSUS230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that complete heart block occurred.The patient was noted to have severe annular and left ventricular outflow tract(lvot) calcification and was selected for a 23 mm lotus edge valve implantation.The physician performed pre-dilation with a 20 mm balloon, according to the instructions for use(ifu).Then the native aortic valve was treated with deployment of a 23 mm lotus edge valve involving successful repositioning of the lotus edge valve with re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).The valve was released in a deep implant position ((non-coronary cusp(ncc) side was about 3mm and left coronary cusp(lcc) side was about 6-7mm)).A few hours post index procedure, the patient went into complete heart block.A permanent pacemaker was implanted to treat the event.The patient had no additional consequences.

• 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: 10546797
• Report Number: 2134265-2020-12480
• Device Sequence Number: 3135006
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/17/2020

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: 09/10/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025727567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention