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

Model Number 20226

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 04/15/2021

Event Type  Injury  

Event Description

It was reported that removal difficulty resulting in stent dislodgement and vessel perforation occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified right common iliac artery.An 8.0x30x135cm express ld iliac stent was advanced for treatment but failed to cross the lesion.The physician tried to pull the stent catheter out; however, it perforated the posterior tibial artery (pta).Swelling was noted, as a result.It was then attempted to be advanced forward where it could be deployed into a larger vessel, but the stent dislodged from the device.A covered stent was placed into the pta after long balloon inflations were deemed unsuccessful, but it was noticed post angiogram that upon sheath exchange, the artery had split open distal to stent placement.At that point, groin antegrade access was obtained and the patient was coiled at the proximal end of the iliac stent.Anterior tibial artery was then wired from groin access and was intervened on in order to give the patient flow back to her feet.The procedure was successfully completed with no additional patient complications reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: 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: 11795602
• MDR Text Key: 249672080
• Report Number: 2134265-2021-05713
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2021

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: 11/09/2023
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0026327859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention