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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 Death (1802)
Date of Event 08/29/2020
Type of Reportable Event Death
Event or Problem Description
It was reported that death occurred.Mild calcium was noted on the native aortic leaflets.Mild bilateral common iliac artery (cia) and femoral calcification and moderate bilateral tortuosity was noted.Vascular access was obtained via a right transfemoral approach.A 15f isleeve introducer sheath was placed.An extra small (xs) safari2 guide wire was positioned.A 27mm lotus edge valve was implanted.No patient complications were reported and the procedure had a successful outcome.Eleven (11) days later, the patient died.An autopsy was not performed.
 
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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 Key10662117
Report Number2134265-2020-13427
Device Sequence Number4284399
Product Code NPT
UDI-Device Identifier08714729960928
UDI-Public08714729960928
Combination Product (Y/N)N
Initial Reporter StateNY
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) 10/12/2020
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 Date08/29/2020
Device Model NumberH749LVSUS270
Device Catalogue NumberH749LVSUS270
Device Lot Number0024842624
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/23/2020
Initial Report FDA Received Date10/12/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
Patient Age83 YR
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