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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 Vascular Dissection (3160)
Date of Event 05/29/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a vessel dissection occurred.The patient's peripheral vessels were highly calcified and small.Intravascular lithotripsy was performed with a non-bsc device.Then right femoral percutaneous access was obtained.A 23mm lotus edge delivery system was advanced and dissected the femoral artery.The dissection was stented successfully.A valve was not implanted.
 
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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 Key10175528
Report Number2134265-2020-07656
Device Sequence Number2925068
Product Code NPT
UDI-Device Identifier08714729960904
UDI-Public08714729960904
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/19/2020
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 Date07/06/2020
Device Model NumberH749LVSUS230
Device Catalogue NumberH749LVSUS230
Device Lot Number0024542981
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/29/2020
Initial Report FDA Received Date06/19/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age88 YR
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