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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 39202
Medical Device Problem Code Activation Failure (3270)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/14/2019
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 in the severely tortuous and mildly calcified superficial femoral artery.A 6x100x120 epic vascular stent was advanced for treatment.However, during deployment the proximal end of the stent started to stack and was deploying within itself.Subsequently, a balloon was inflated and dragged within the stent to remedy the proximal end of the stent.The stent delivery system was removed and there was no patient complications reported.The patient was fine post procedure.
 
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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 Key9255409
Report Number2134265-2019-13117
Device Sequence Number14393691
Product Code NIO
UDI-Device Identifier08714729805205
UDI-Public08714729805205
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) 10/30/2019
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 Model Number39202
Device Catalogue Number39202
Device Lot Number0024333055
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/14/2019
Initial Report FDA Received Date10/30/2019
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;
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