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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 Positioning Problem (3009)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent positioning difficulties were encountered.A 9.0x60x75cm express ld stent was advanced for treatment.However, the stent moved during deployment.The stent was well opposed to the vessel wall and a new stent was deployed due to the stent moving and the procedure was completed.No patient complications were reported and patient's status was stable.
 
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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 Key8716563
Report Number2134265-2019-07054
Device Sequence Number2073044
Product Code NIO
UDI-Device Identifier08714729392354
UDI-Public08714729392354
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/20/2019
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 Date07/12/2021
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0022370830
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/10/2019
Initial Report FDA Received Date06/20/2019
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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