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	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date ((b)(6) 2021) as no event date was provided.
Event or Problem Description
It was reported that the stent dislodgement occurred.Two 7.0x30x75cm express ld iliac / biliary stents were selected to treat the lesion.However, during delivery, both stents fell off the balloon.Subsequently, a snare was used to remove the stents.The procedure was completed with another of the same device.No further patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Correction (e1): updated physician's details update (b3) date of event: updated to (b)(6) 2021.
Event or Problem Description
It was reported that the stent dislodgement occurred.Two 7.0x30x75cm express ld iliac / biliary stents were selected to treat the lesion.However, during delivery, both stents fell off the balloon.Subsequently, a snare was used to remove the stents.The procedure was completed with another of the same device.No further patient complications reported and the patient was fine.It was further reported that the target lesion was located in the severely calcified and tortuous common illiac artery.

• 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: 11485379
• Report Number: 2134265-2021-02640
• Device Sequence Number: 19686338
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/25/2021

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: 07/20/2023
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0025741431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention