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

Model Number 20226

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

A2.Age at time of event updated.B5.Describe event or problem updated.H6.Device code updated.

Event 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
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12122632
• MDR Text Key: 260087491
• Report Number: 2134265-2021-08546
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (y/n): N
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR