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 Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgment occured.The target lesion was located in the iliac artery.A 6.0 x 20 x 75cm express ld iliac stent was advanced for treatment.However, the stent was detached from the delivery balloon.The device was successfully removed from the patient including its delivery catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent mounted onto the balloon.A visual examination of the returned device confirmed that the balloon had not been subjected to positive pressure.No issues were noted with the balloon material.The device was received with stent crimped in the correct position on the balloon of the delivery system.A visual and microscopic examination identified no damage or issues with the stent that could potentially have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip that could possibly have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgment occured.The target lesion was located in the iliac artery.A 6.0 x 20 x 75cm express ld iliac stent was advanced for treatment.However, the stent was detached from the delivery balloon.The device was successfully removed from the patient including its delivery catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• 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: 8423122
• Report Number: 2134265-2019-02448
• Device Sequence Number: 13902078
• Product Code: NIO
• UDI-Device Identifier: 08714729392132
• UDI-Public: 08714729392132
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 05/02/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022072540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1