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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 H749LVSUS270
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Arrhythmia (1721)
Date of Event 11/03/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that left bundle branch block (lbbb) occurred.The patient was selected for a 27mm lotus edge valve implant.After the valve was successfully implanted, new onset of lbbb occurred.A permanent pacemaker was implanted.The patient is doing well.
 
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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 Key10885996
Report Number2134265-2020-16180
Device Sequence Number16843950
Product Code NPT
UDI-Device Identifier08714729960928
UDI-Public08714729960928
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P180029
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 11/23/2020
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 NumberH749LVSUS270
Device Catalogue NumberH749LVSUS270
Device Lot Number0025828991
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/03/2020
Initial Report FDA Received Date11/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		92630745-FA
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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