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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 Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The more than 50% stenosed target lesion was located in the moderately tortuous and non-calcified right iliac artery.Arteriogram procedure was performed.The physician wanted to insert a 7.0x60x135 cm express ld iliac / biliary stent; however, the stent did not advance over the guidewire and it was noticed that the device was kinked.Another express ld stent of the same size was used and completed the procedure.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: a express ld device was returned for analysis.The investigator successfully loaded a boston scientific 0.035 in guidewire through the express device and removed it with no resistance being encountered.No issues were identified with the device that could potentially have contributed to the complaint incident.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.An examination of the crimped stent identified that the proximal end of the stent was damaged where the stent had been pushed proximally over the proximal balloon cone and a stent strut at the distal end was raised.A visual and tactile examination identified no issues with the shaft of the device.A visual and tactile examination identified no issues with tip of this device.This concludes the product analysis.
 
Event Description
It was reported that stent damage occurred.The more than 50% stenosed target lesion was located in the moderately tortuous and non-calcified right iliac artery.Arteriogram procedure was performed.The physician wanted to insert a 7.0x60x135 cm express ld iliac / biliary stent; however, the stent did not advance over the guidewire and it was noticed that the device was kinked.Another express ld stent of the same size was used and completed the procedure.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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13995621
MDR Text Key288494121
Report Number2134265-2022-03882
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392453
UDI-Public08714729392453
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 05/03/2022
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
Device Operator Health Professional
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0028014875
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2022
Initial Date FDA Received04/04/2022
Supplement Dates Manufacturer Received04/26/2022
Supplement Dates FDA Received05/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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