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

Model Number	20226
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The stenosed target lesion was located in the iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment but could not cross the lesion.The physician decided to withdraw the stent to pre-dilate the lesion.However, after removing the device out of the sheath, it was noted that the stent was no longer attached to the stent delivery system balloon.Upon imaging, the stent was found lodged at the end of the sheath.The physician was not able to remove the stent from the artery.The physician advanced the stent near the lesion to fully deploy it.The stent was then fully deployed but not in the optimal location.Subsequently, a second stent was placed to fully cover the lesion.The procedure was completed successfully and there were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The stenosed target lesion was located in the iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment but could not cross the lesion.The physician decided to withdraw the stent to pre-dilate the lesion.However, after removing the device out of the sheath, it was noted that the stent was no longer attached to the stent delivery system balloon.Upon imaging, the stent was found lodged at the end of the sheath.The physician was not able to remove the stent from the artery.The physician advanced the stent near the lesion to fully deploy it.The stent was then fully deployed but not in the optimal location.Subsequently, a second stent was placed to fully cover the lesion.The procedure was completed successfully and there were no patient complications nor injuries reported.It was further reported that the target lesion was 90% stenosed, non-tortuous and mildly calcified.

• 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: 10547119
• Report Number: 2134265-2020-12875
• Device Sequence Number: 2992593
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 06/11/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0023939666
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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: 71 YR