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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC Back to Search Results
Model Number 20300
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 04/23/2019
Event Type  malfunction  
Event Description
It was reported that inadvertent stent deployment occurred.A 7x60x120mm epic stent was selected for use.When the device was removed from the packaging during preparation, the distal tip of the stent was found to be released.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is sticking out 2mm past the distal end of the middle sheath.Microscopic examination revealed no additional damages.There is blood in the middle sheath.Inspection of the remainder of the device presented no damage or irregularities.
 
Event Description
It was reported that inadvertent stent deployment occurred.A 7x60x120mm epic stent was selected for use.When the device was removed from the packaging during preparation, the distal tip of the stent was found to be released.No patient complications were reported.
 
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Brand Name
EPIC
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8654614
MDR Text Key146519134
Report Number2134265-2019-06075
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/23/2020
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
Device Operator Health Professional
Device Expiration Date01/09/2021
Device Model Number20300
Device Catalogue Number20300
Device Lot Number0021595084
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Initial Date Manufacturer Received 05/20/2019
Initial Date FDA Received05/30/2019
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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