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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 Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: above 18 years and older.
 
Event or Problem Description
It was reported that stent damage occurred.A 10.0x40x135 cm express ld iliac biliary stent was selected for use for a stenting procedure in the arm.However, during preparation, it was noted that the end of the stent was deformed.The procedure was completed with different device.No patient complications reported and the patient's status was stable.
 
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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 Key8413453
Report Number2134265-2019-02365
Device Sequence Number13558133
Product Code NIO
UDI-Device Identifier08714729392385
UDI-Public08714729392385
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K133110
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/12/2019
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 Date03/08/2019
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0019009211
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2019
Initial Report FDA Received Date03/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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