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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 Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2022
Event Type  malfunction  
Event Description
It was reported that balloon leak occurred.The patient presented with severe left external iliac artery (eia) stenosis.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified left eia.There was quite a large calcium shelf in the vessel.A 8.0x40x135 cm express ld iliac / biliary stent was advanced; however, during inflation, a contrast was noticed coming from the bottom of the balloon and the balloon would not inflate.The physician thought that it may be the large calcium shelf that caused a pinpoint hole in the bottom of the balloon.The device was removed in whole, and the procedure was completed with a new express ld stent.No patient complications nor injuries were reported.
 
Manufacturer Narrative
(e1) (b)(6).
 
Event Description
It was reported that balloon leak occurred.The patient presented with severe left external iliac artery (eia) stenosis.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified left eia.There was quite a large calcium shelf in the vessel.A 8.0x40x135 cm express ld iliac / biliary stent was advanced; however, during inflation, a contrast was noticed coming from the bottom of the balloon and the balloon would not inflate.The physician thought that it may be the large calcium shelf that caused a pinpoint hole in the bottom of the balloon.The device was removed in whole, and the procedure was completed with a new express ld stent.No patient complications nor injuries were reported.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15865230
MDR Text Key307588498
Report Number2124215-2022-48997
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392477
UDI-Public08714729392477
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,Followup
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2022
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 Number0029080439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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