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

Model Number	20226
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement, shaft break, and thrombosis occurred.The 80% stenosed target lesion was located in the non-tortuous and mildly calcified right common iliac artery.An 8.0x40x135 cm express ld iliac / biliary stent was advanced for treatment.However, during the procedure, the stent came off the balloon and lodged into the anterior tibial artery.The dislodged stent was wedged into the artery which clotted off.While trying to remove the dislodged stent from the unintended artery, the balloon catheter broke at the proximal balloon connection and both balloon and stent remained in the body.Multiple attempts were made to remove and snare the balloon and stent from the artery but failed.Eventually all attempts were ceased and the procedure was terminated.
Additional Manufacturer Narrative
Device evaluated by mfr: an express ld device was returned for analysis.Device analysis confirmed that a break had occurred in the shaft and the distal section of the break including the balloon, tip and markerbands were not received with the device for analysis.The stent was not returned with the device.A break was confirmed in the shaft.The break was located at 1290mm distal from the distal end of the strain relief.The distal section of the break was not received for analysis.There were multiple shaft kinks noted along the length of the shaft.No other issues were identified with the returned device during analysis.
Event or Problem Description
It was reported that stent dislodgement, shaft break, and thrombosis occurred.The 80% stenosed target lesion was located in the non-tortuous and mildly calcified right common iliac artery.An 8.0x40x135 cm express ld iliac / biliary stent was advanced for treatment.However, during the procedure, the stent came off the balloon and lodged into the anterior tibial artery.The dislodged stent was wedged into the artery which clotted off.While trying to remove the dislodged stent from the unintended artery, the balloon catheter broke at the proximal balloon connection and both balloon and stent remained in the body.Multiple attempts were made to remove and snare the balloon and stent from the artery but failed.Eventually all attempts were ceased and the procedure was terminated.

• 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: 12167526
• Report Number: 2134265-2021-08893
• Device Sequence Number: 3988867
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/09/2021

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: 03/18/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0026997895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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: Required Intervention
• Patient Age: 60 YR