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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 H749LVSUS250
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Complete Heart Block (2627)
Date of Event 05/19/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that complete heart block (chb) occurred.Vascular access was obtained via a transfemoral approach.A lotus introducer was placed.A small safari2 guide wire was positioned.The mild to moderately calcified native aortic valve was treated with the successful implant of a 25mm lotus edge valve.No paravalvular leak (pvl) was noted.At an unknown time, the patient developed chb.A permanent pacemaker was implanted.No patient complications were 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 Key10669695
Report Number2134265-2020-13403
Device Sequence Number2728270
Product Code NPT
UDI-Device Identifier08714729960911
UDI-Public08714729960911
Combination Product (Y/N)N
Initial Reporter StateMO
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) 10/13/2020
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 Date06/28/2020
Device Model NumberH749LVSUS250
Device Catalogue NumberH749LVSUS250
Device Lot Number0024498131
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/19/2020
Initial Report FDA Received Date10/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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