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

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stent damage occurred.A 7.0x60x75cm express ld iliac / biliary was selected for use in the right common iliac.The device would not cross the lesion.When the device was attempted to be removed, it would not come off the sheath but through the sheath.Upon removal, damage was observed on the edge of the stent.Another of the same device along with a longer sheath was used to complete the procedure.There were no patient complications.
Event or Problem Description
It was reported stent damage occurred.A 7.0x60x75cm express ld iliac / biliary was selected for use in the right common iliac.The device would not cross the lesion.When the device was attempted to be removed, it would not come off the sheath but through the sheath.Upon removal, damage was observed on the edge of the stent.Another of the same device along with a longer sheath was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual and microscopic examination was performed on the returned device.The delivery system was returned for analysis with stent fully attached to the delivery system.The device was returned inserted into the customer's 6fr sheath.A visual and microscopic examination was performed on the returned stent.The stent was fully crimped onto the delivery system.One strut on the distal section of the stent was noted to be lifted from the rest of the stent.This lifted stent strut prevented the investigator from removing the device from the sheath.The balloon was noted to be tightly folded and had not been subjected to positive pressure.During analysis the investigator successfully inflated the balloon material and deployed the stent with no issues noted.A visual and microscopic examination of the device identified no damage or any issues with the tip or markerbands that could have contributed to the complaint incident.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: 8170238
• Report Number: 2134265-2018-64421
• Device Sequence Number: 13812369
• Product Code: NIO
• UDI-Device Identifier: 08714729392231
• UDI-Public: 08714729392231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/06/2019

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: 09/13/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022654274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/20/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR