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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/17/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right iliac artery.Following pre-dilatation, a 8x80x120 epic vascular stent was advanced over a non-bsc guidewire.However, upon removal, the stent delivery system was stuck on the guidewire and could not be pulled out so the delivery system was removed together with the guidewire.No patient complications nor injuries were reported and the patient condition was good.
 
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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 Key11616311
Report Number2134265-2021-03760
Device Sequence Number2998693
Product Code NIO
UDI-Device Identifier08714729805724
UDI-Public08714729805724
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P110035
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/05/2021
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 Date07/08/2023
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0022350617
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/17/2021
Initial Report FDA Received Date04/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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