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	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that stent dislodgement occurred.The stenosed target lesion was located in the iliac artery.A 6.0 x 60 x 135 cm express ld iliac / biliary stent was advanced for treatment.However, during procedure, it was noted that the device was released occasionally before reaching to the lesion.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Event or Problem Description
It was reported that stent dislodgement occurred.The stenosed target lesion was located in the iliac artery.A 6.0 x 60 x 135 cm express ld iliac / biliary stent was advanced for treatment.However, during procedure, it was noted that the device was released occasionally before reaching to the lesion.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.It was further reported that the stent was opened already before the balloon started inflating.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older device evaluated by mfr: an express ld device was returned for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.An examination of the crimped stent identified that the mid section of the stent was damaged, and the stent was pulled in a distal direction over the distal markerband and tip.A visual and tactile examination identified no issues with the shaft of the device.The investigator removed the stent in order to view the markerbands and tip.A visual examination identified no issues with tip or markerbands of this device.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: 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: 14470277
• Report Number: 2134265-2022-05040
• Device Sequence Number: 11888911
• Product Code: NIO
• UDI-Device Identifier: 08714729392422
• UDI-Public: 08714729392422
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027535866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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
• Patient Sex: Unknown