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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The 50% stenosed target lesion was located in the non-tortuous but severely calcified left subclavian vessel.A 7.0x30x135cm express ld iliac / biliary stent was advanced for treatment.However, during the procedure, it was noted that the stent came off and it was removed through the sheath.The procedure was completed with a new stent.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The 50% stenosed target lesion was located in the non-tortuous but severely calcified left subclavian vessel.A 7.0x30x135cm express ld iliac/biliary stent was advanced for treatment.However, during the procedure, it was noted that the stent came off and it was removed through the sheath.The procedure was completed with a new stent.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: express-b-i ld, pmtd, 7.0x30x135cm was received for analysis.A visual and microscopic examination identified that the stent had completely detached from the device.The detached stent was not returned for analysis.A microscopic examination identified that the stent of the device had completely detached from the balloon catheter.There was no evidence indicating that the balloon had been inflated.No issues with the balloon material were noted that could potentially have contributed to the complaint incident.Stent crimp marks were clearly evident on the balloon material.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the shaft of the device.No other issues were identified during the product analysis.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12235984
• Report Number: 2134265-2021-09484
• Device Sequence Number: 14445670
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2021

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: 02/17/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0026823974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1