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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 Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that stent foreshortening occurred.The 75% stenosed target lesion was located in a moderately tortuous and moderately calcified iliac artery.A 10x40x75 epic (epic vascular) stent was selected for use.During deployment, the physician intended to apply tension properly during deployment; however, the device was eventually shortened.Subsequently, an additional stent was placed and the procedure was completed with a different device.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 Key10184103
Report Number2134265-2020-08346
Device Sequence Number2706891
Product Code NIO
UDI-Device Identifier08714729805014
UDI-Public08714729805014
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P110035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date05/21/2024
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0023843038
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/17/2020
Initial Report FDA Received Date06/23/2020
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 Other;
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