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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number 20226
Medical Device Problem Codes Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/11/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported stent damage occurred.A 8.0x30x75cm express ld iliac / biliary was selected for use in the left external iliac vein.The stent was initially unable to pass through the lesion.The device was removed so that pre-dilation could be performed.When the stent was viewed upon removal.The end of the stent was damaged.Another of the same device was used to complete the procedure.There were no patient complications and the patient is fine.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Common Device Name
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8170144
Report Number2134265-2018-64420
Device Sequence Number1697105
Product Code NIO
UDI-Device Identifier08714729579670
UDI-Public08714729579670
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K133110
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/17/2018
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
Operator of Device Health Professional
Device Expiration Date08/07/2021
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0022478163
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2018
Initial Report FDA Received Date12/17/2018
Patient Sequence Number1
Patient Age63 YR
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