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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 Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/13/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 8.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, during procedure, it was noted that the stent was detached and had to be implanted in a healthy artery.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
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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 Key12537168
Report Number2134265-2021-11909
Device Sequence Number11100403
Product Code NIO
UDI-Device Identifier08714729579670
UDI-Public08714729579670
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K133110
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/27/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date11/27/2023
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0026429095
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/13/2021
Initial Report FDA Received Date09/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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