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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 Codes Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/12/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in an iliac vessel.A 7.0x20x75cm express ld iliac / biliary stent was advanced to treat the lesion.However, when the device was attempted to be removed, the device got caught in the cross cut valve of the sheath and the stent came off the balloon outside the patient's body.The procedure was completed with another of the same device.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 Key8029285
Report Number2134265-2018-62527
Device Sequence Number13791204
Product Code NIO
UDI-Device Identifier08714729392194
UDI-Public08714729392194
Combination Product (Y/N)N
Initial Reporter StateLA
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) 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/07/2020
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0021359202
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2018
Initial Report FDA Received Date11/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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