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

Model Number	20226
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device migration and surgical intervention occurred.The target lesion was located in arterial iliofemoral.A 7.0x40x75cm express-b-i ld stent was implanted.However, device migration occurred and surgical femoral cut down was performed and the procedure was completed successfully.There were no patient complications reported and the patient was fully recovered.
Additional Manufacturer Narrative
A2.Age at time of event updated.B5.Describe event or problem updated.H6.Device code updated.
Event or Problem Description
It was reported that device migration and surgical intervention occurred.The target lesion was located in arterial iliofemoral.A 7.0x40x75cm express-b-i ld stent was implanted.However, device migration occurred and surgical femoral cut down was performed and the procedure was completed successfully.There were no patient complications reported and the patient was fullly recovered.It was further reported via medwatch (b)(4), that the catheter was within the left common femoral artery.When it was pulled back, the catheter tip detached.

• 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: 12122632
• Report Number: 2134265-2021-08546
• Device Sequence Number: 17308463
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/07/2021

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: 09/30/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024519564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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
• Patient Age: 62 YR