MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: 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 Key: 13995621
• Report Number: 2134265-2022-03882
• Device Sequence Number: 4372866
• Product Code: NIO
• UDI-Device Identifier: 08714729392453
• UDI-Public: 08714729392453
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0028014875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female