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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 Codes Death (1802); Low Blood Pressure/ Hypotension (1914); Aortic Dissection (2491)
Date of Event 10/13/2020
Type of Reportable Event Death
Event or Problem Description
It was reported that aortic dissection and death occurred.A 23mm lotus edge valve was successfully implanted.No indication of aortic dissection was present during the transcatheter aortic valve replacement procedure.Early in the morning on the day following the implant procedure, the patient was taken to surgery to investigate hypotensive events the patient had experienced overnight.An aortic dissection was noted below the left renal down to the left common iliac (lci).The patient was made "do not resuscitate" (dnr) status by the family and died during surgery.
 
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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 Key10775158
Report Number2134265-2020-14528
Device Sequence Number14424102
Product Code NPT
UDI-Device Identifier08714729960904
UDI-Public08714729960904
Combination Product (Y/N)N
Initial Reporter StateFL
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) 11/02/2020
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 Date12/03/2020
Device Model NumberH749LVSUS230
Device Catalogue NumberH749LVSUS230
Device Lot Number0026041895
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/14/2020
Initial Report FDA Received Date11/02/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Death; Other;
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