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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the common iliac artery.An 8.0x40x75cm express ld stent was advanced for treatment.During the procedure, the stent came off from the balloon prior to deployment.An 8 x 60 x 130 innova vascular stent was used to trap the express ld stent up against the wall vessel.However, the innova stent did not reach the desired target area for placement.The physician plans to send back the patient to stent the intended area.No complications were reported.
Additional Manufacturer Narrative
H6 - added f05: delay to treatment/therapy impact code.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the common iliac artery.An 8.0x40x75cm express ld stent was advanced for treatment.During the procedure, the stent came off from the balloon prior to deployment.An 8 x 60 x 130 innova vascular stent was used to trap the express ld stent up against the wall vessel.However, the innova stent did not reach the desired target area for placement.The physician plans to send back the patient to stent the intended area.No complications were reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18360738
• Report Number: 2124215-2023-71828
• Device Sequence Number: 12766054
• Product Code: NIO
• UDI-Device Identifier: 08714729392279
• UDI-Public: 08714729392279
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 03/23/2026
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0031297470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown