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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 Activation Failure (3270)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/23/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent did not fully expand post deployment.The target lesion was located in the left superficial femoral artery.A 7x80x120mm epic vascular stent was advanced for treatment.However, it was noted that the stent failed to fully expand.Secondary stenting was performed to complete the procedure.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 Key8855564
Report Number2134265-2019-09152
Device Sequence Number2548183
Product Code NIO
UDI-Device Identifier08714729805526
UDI-Public08714729805526
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P110035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/02/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date05/27/2023
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0022175826
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2019
Initial Report FDA Received Date08/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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