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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
Device Problem Misassembled (1398)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that missing marker bands occurred.The target lesion was located in the biliary duct.A 10x80x75mm epic stent was opened however, prior to loading on the wire, it was noted that distal markers were missing.The procedure was completed with another of the same device.No patient complications were reported and patient status was good.
 
Event Description
It was reported that missing marker bands occurred.The target lesion was located in the biliary duct.A 10x80x75mm epic stent was opened however, prior to loading on the wire, it was noted that distal markers were missing.The procedure was completed with another of the same device.No patient complications were reported and patient status was good.
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer shaft, inner shaft, and tip were visually and microscopically examined.Visual examination revealed that the stent is partially deployed 1.5mm from the middle sheath.Microscopic examination revealed no additional damages.The lock is still on the rack.Inspection of the remainder of the device presented no other damage or irregularities.
 
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Brand Name
EPIC VASCULAR
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9376114
MDR Text Key174189097
Report Number2134265-2019-14446
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805090
UDI-Public08714729805090
Combination Product (y/n)N
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0024177754
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Date Manufacturer Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
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