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

Model Number	20226
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.After a 7fr sheath was inserted, a 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, it was noted that the stent became stuck in the sheath and was unable to deploy upon insertion.Upon removal of the balloon, the stent was captured by the balloon.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.After a 7fr sheath was inserted, a 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, it was noted that the stent became stuck in the sheath and was unable to deploy upon insertion.Upon removal of the balloon, the stent was captured by the balloon.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received for analysis.A visual and microscopic examination identified that the stent had been moved to position that was approximately 7mm proximal of the proximal balloon sleeve on the device.A microscopic examination found the first two rows of the distal stent struts to be damaged.The stent damage most probably occurred when attempting to insert the device into the sheath.No other issues were identified with the stent that could potentially have contributed to the complaint incident.A visual examination identified that the balloon had been subjected to positive pressure.It is not known when or why the balloon was inflated.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device.No other issues were identified during the product analysis.

• 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: 10051998
• Report Number: 2134265-2020-06360
• Device Sequence Number: 11472024
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: 02/10/2023
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0025192518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1