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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 Consequences Or Impact To Patient (2199)
Date of Event 05/23/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right common iliac artery (cia).A 8.0x30x135cm express ld iliac / biliary stent was advanced for treatment.However, upon deployment, the stent came off the balloon.It was attempted to steer the dislodged stent back, but the stent had to be deployed in the right profunda artery.Dilatation was performed and the stent was implanted.A second, larger, 9x27mm stent was then advanced and was placed in the cia to complete the procedure.No patient complications were 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 Key8663297
Report Number2134265-2019-06223
Device Sequence Number2182313
Product Code NIO
UDI-Device Identifier08714729579700
UDI-Public08714729579700
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K133110
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/03/2019
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 Date09/03/2020
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0021090149
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/23/2019
Initial Report FDA Received Date06/03/2019
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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