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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM
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BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM Back to Search Results
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 10/14/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient experienced complete heart block (chb).A patient was selected for a 23mm lotus edge valve implant.The aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 23mm lotus edge valve.Prior to the balloon valvuloplasty, the patient developed bundle branch block and then after the valve deployment began, the patient went into chb.A permanent pacemaker was implanted after the valve implant procedure in order to treat the chb.There were no further patient consequences reported.
 
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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 Key10778296
Report Number2134265-2020-15081
Device Sequence Number3645748
Product Code NPT
UDI-Device Identifier08714729960904
UDI-Public08714729960904
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2020
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 Date12/08/2020
Device Model NumberH749LVSUS230
Device Catalogue NumberH749LVSUS230
Device Lot Number0025817149
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/14/2020
Initial Report FDA Received Date11/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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