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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC Back to Search Results
Model Number 39200
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/05/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered.The 99% stenosed target lesion was located in the severely tortuous and moderately calcified common iliac artery.A 10x40x120 epic vascular stent was advanced for treatment.However, during the release, the thumb wheel was very hard and very risky.It was also noted that the shaft may have been stuck and was difficult to push and was possible to pull.Eventually, the device was able to remove without any problems and the procedure was completed with a different device.There were no patient complications nor injuries reported.
 
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Brand Name
EPIC VASCULAR
Common Device Name
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10971075
Report Number2134265-2020-17078
Device Sequence Number4294871
Product Code NIO
UDI-Device Identifier08714729805007
UDI-Public08714729805007
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P110035
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/13/2022
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0020887838
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/23/2020
Initial Report FDA Received Date12/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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