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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 Problems Difficult to Insert (1316); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2022
Event Type  malfunction  
Event Description
It was reported that inadvertent deployment occurred.The target lesion was located in a severely tortuous vessel in the left forearm.A 9x40x75 epic vascular stent was selected for use.However, during preparation, the physician attempted to load the stent onto the guidewire but could not advance it into the sheath because the stent started to deploy.They tried to see if the stent would get covered by delivery system but could not.The procedure was completed with an innova self-expanding stent.No patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15547050
MDR Text Key302717456
Report Number2124215-2022-36732
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805793
UDI-Public08714729805793
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/05/2022
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 Model Number39200
Device Catalogue Number39200
Device Lot Number0029475219
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/13/2022
Initial Date FDA Received10/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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