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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 Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2023
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the renal artery.A 8.0x20x135 cm express ld stent was selected for use.However, it was found that the balloon was already expanded when unwrapping the package.The device was not used and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.
 
Event Description
It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the renal artery.A 8.0x20x135 cm express ld stent was selected for use.However, it was found that the balloon was already expanded when unwrapping the package.The device was not used and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.
 
Manufacturer Narrative
H6 - device codes: corrected to material integrity problem.Device evaluated by mfr.: express-b-i ld pmtd 8.0x20x135 cm was received for analysis.The indicated introducer sheath size for this express ld device is a 6fr.The customer's sheath was not returned for analysis.During analysis the investigator successfully advanced the device through a boston scientific 6fr sheath without any resistance or issues noted.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination found the stent crimped in the correct location on the balloon with no evidence of damage or any other issues noted.No issues were noted with the tip of the device.A visual and tactile examination identified no kinks or issues with the shaft of the device.
 
Manufacturer Narrative
H6 - device codes: corrected to material integrity problem.
 
Event Description
It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the renal artery.A 8.0x20x135 cm express ld stent was selected for use.However, it was found that the balloon was already expanded when unwrapping the package.The device was not used and completed the procedure with another of same device.There were no patient complications reported.Patient was stable.
 
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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 Key17939061
MDR Text Key325722659
Report Number2124215-2023-54289
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392460
UDI-Public08714729392460
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2023
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 Number0028471835
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2021
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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