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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 Foreign Body In Patient (2687)
Date of Event 03/15/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred via attached medwatch mw5100114.The target lesion was located in the mesenteric artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, during procedure, the stent broke off the balloon and traveled into the aorta and landed in the occluded left iliac vessel.No further information available.
 
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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 Key11777875
Report Number2134265-2021-05522
Device Sequence Number3647406
Product Code NIO
UDI-Device Identifier08714729579694
UDI-Public08714729579694
Combination Product (Y/N)N
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 user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/05/2021
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 Date09/18/2021
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0022674437
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/15/2021
Initial Report FDA Received Date05/05/2021
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 Other;
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