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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
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.A 9.0x30x75cm express ld iliac / biliary stent balloon was advanced for treatment.However, during the preparation, it was found that the stent was not attached to the delivery system when pulling out from the loop.The procedure was completed with a different device.There were no patient complications reported.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19101418
MDR Text Key340463573
Report Number2124215-2024-21979
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392316
UDI-Public08714729392316
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0030625442
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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