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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 Migration (4003)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/08/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent migration occurred.A 7x40x120 epic vascular stent was advanced for treatment.However, during the procedure, it was noted that the stent slip down stream and distally migrated after initial implant.Balloon angioplasty was performed and the procedure was completed.There were no patient complications nor injuries reported and the patient was fully recovered.
 
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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 Key12307490
Report Number2134265-2021-10113
Device Sequence Number3611538
Product Code NIO
UDI-Device Identifier08714729805441
UDI-Public08714729805441
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P110035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/11/2021
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 Date11/01/2025
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0026288046
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2021
Initial Report FDA Received Date08/11/2021
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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