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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred and the patient was sent to surgery.The target lesion was located in the mesenteric artery.A 8.0x20x135 cm express ld iliac/biliary stent was advanced for treatment.However, during the procedure, the stent was dislodged and the patient was sent to surgery to remove the device.There were no further patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred and the patient was sent to surgery.The target lesion was located in the mesenteric artery.A 8.0x20x135 cm express ld iliac/biliary stent was advanced for treatment.However, during the procedure, the stent was dislodged and the patient was sent to surgery to remove the device.There were no further patient complications reported.It was further reported that the dislodged stent was pulled down to the common femoral artery and was retrieved intact by surgically opening the groin area.The patient condition post procedure was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: a express ld device was returned for analysis.The balloon was received tightly folded with no stent attached.The stent was not returned with the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination of the device identified no issues with the markerbands or tip that could have contributed to the complaint incident.This concludes the product analysis.B2-outcomes attrib to adv event: removed other serious (important medical events) h6-patient codes: updated from insufficient information to no clinical signs, symptoms or conditions.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14842813
• Report Number: 2134265-2022-06963
• Device Sequence Number: 2351011
• Product Code: NIO
• UDI-Device Identifier: 08714729392460
• UDI-Public: 08714729392460
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0028776732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown