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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 Consequences Or Impact To Patient (2199)
Date of Event 09/16/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage occured.The target lesion was located in the proximal right common iliac artery.A 7.0 x 60 x 135 cm express ld iliac / biliary stent was advanced; however, resistance was encountered and it would not advanced to the lesion.The physician pulled the stent out and it was noted that the disal end of the stent was crimped or razed.Another 7.0 x 60 x 135 cm express ld iliac / biliary stent was advanced and completed the procedure.No patient complications were reported and the patient's status was 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 Key9114238
Report Number2134265-2019-11633
Device Sequence Number2057126
Product Code NIO
UDI-Device Identifier08714729392453
UDI-Public08714729392453
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) 09/24/2019
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 Date07/15/2022
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0024112681
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/16/2019
Initial Report FDA Received Date09/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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