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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reocclusion (1985)
Event Date 06/04/2019
Event Type  Injury  
Event Description
It was reported that in-stent restenosis occurred.Vascular access was obtained via a femoral artery.A 7x120x120 epic stent was advanced and deployed in a left external iliac at the sight of stenosis.Pre and post-dilatation was successfully performed.However, few weeks post procedure, the patient was observed with in-stent restenosis.Pre-dilatation was performed and another 7x120x120 epic stent was implanted.No further adverse event was reported and the patient's status was stable.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8798965
MDR Text Key151323026
Report Number2134265-2019-08299
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/17/2019
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? No
Device Operator Health Professional
Device Expiration Date10/25/2021
Device Model Number20300
Device Catalogue Number20300
Device Lot Number0022848410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received07/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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