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

Model Number	20226
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 83% stenosed target lesion was located in the moderately tortuous and severely calcified right common iliac artery.After a 7x10 non boston scientific sheath was placed, a.035 guidewire was inserted along with pigtail then exchanged for a.018x300 steel core wire to perform intravenous ultrasound (ivus).After ivus the pigtail was reinserted and wire exchange was performed with.035 wire.A 10.0 x 40 x 135 cm express ld iliac / biliary stent was advanced for treatment and the device could not advance past the lesion.The physician then exchange to a longer sheath but upon removal of the stent the stent was stripped from the balloon at the edge of the sheath.The sheath was then removed to be exchanged for a 7x23cm sheath.Fluoroscopy was performed revealing the stent on the wire in the common femoral artery (cfa).A dilator was advanced into the stent to hold it in place, and surgery was called for removal.A cutdown of the right common femoral artery was then performed and stent was removed.The patient will be brought back for stent of common iliac artery.No further patient complications were reported and the patient was fully recovered.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12883706
• Report Number: 2134265-2021-14733
• Device Sequence Number: 4024858
• Product Code: NIO
• UDI-Device Identifier: 08714729392385
• UDI-Public: 08714729392385
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 11/29/2021

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: 08/08/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027801276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female