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

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11795602
• Report Number: 2134265-2021-05713
• Device Sequence Number: 3972539
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/09/2021
• 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: Other; Required Intervention