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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 06/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: (b)(6) 2019 - used the first date of the month of the aware date as no event date was provided.
 
Event or Problem Description
It was reported that stent dislodgment occured.The target lesion was located in the iliac artery.A 6.0mm x 60mm x 135 cm express ld stent was advanced for treatment.However, it was noted that the stent came off the balloon.The procedure was completed with another of the same device.There were no patient complications were reported and the patient 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 Key8790156
Report Number2134265-2019-08175
Device Sequence Number19290719
Product Code NIO
UDI-Device Identifier08714729392422
UDI-Public08714729392422
Combination Product (Y/N)N
Initial Reporter StateOH
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) 07/15/2019
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 Date09/16/2020
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0021143427
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2019
Initial Report FDA Received Date07/15/2019
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;
Patient Age68 YR
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