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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 Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/01/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the stent delivery system became stuck on the guidewire.The 99% stenosed target lesion was located in the severely tortuous and severely calcified iliac artery.After advancing the lesion with a 0.035 non-bsc guidewire, a 10x80x75mm epic stent was advanced for treatment.However, it was noted to have stuck midway, and the device was removed together with the wire.The procedure was completed with a different device and no patient complications were 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 Key8523604
Report Number2134265-2019-03997
Device Sequence Number11435298
Product Code NIO
UDI-Device Identifier08714729805090
UDI-Public08714729805090
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,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/17/2019
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 Date07/24/2023
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0022425700
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/01/2019
Initial Report FDA Received Date04/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
6FR PARENT; RADIFOCUS ANGLE GUIDEWIRE
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