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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 Problems Difficult to Insert (1316); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that stent prematurely deployment occurred.An 8x60x75 epic stent was selected for use for a patient procedure.However, resistance was felt when inserting the stent and when removed, the tip of the stent was found to be deployed for about 1mm.The stopper of the handle part was not released, so an issue of the device occurred during unpacking might be possible.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital.(b)(6).Device evaluated by mfr.: the epic was returned to boston scientific for analysis.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination showed a kink 6.5 cm from the distal end of the sheath.Microscopic examination revealed 1mm partial deployment of the stent.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that stent premature deployment occurred.An 8x60x75 epic stent was selected for use for a patient procedure.However, resistance was felt when inserting the stent and when removed, the tip of the stent was found to be deployed for about 1mm.The stopper of the handle part was not released, so an issue of the device occurred during unpacking might be possible.The procedure was completed with another of the same device.There were no patient complications nor injuries 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 Key12059001
MDR Text Key258109987
Report Number2134265-2021-07840
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 07/19/2021
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
Device Operator Health Professional
Device Expiration Date10/09/2022
Device Model Number20300
Device Catalogue Number20300
Device Lot Number0024575142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Initial Date Manufacturer Received 06/03/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received06/29/2021
Supplement Dates FDA Received07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS
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