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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 No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/02/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a severely tortuous iliac artery.A 8.0x40x75cm express ld stent was advanced for treatment.However, the stent dislodged inside patient.It was retrieved through snaring and was completely removed.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 Key11516258
Report Number2134265-2021-02995
Device Sequence Number11813255
Product Code NIO
UDI-Device Identifier08714729392279
UDI-Public08714729392279
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
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) 03/18/2021
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 Date11/25/2023
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0026422324
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/02/2021
Initial Report FDA Received Date03/18/2021
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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