MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number	H74938046830750
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.The sheath used during the procedure was not returned for analysis.A stringy clear material was noted to be attached to the stent on the express ld device.The express ld device was returned with the stent fully mounted onto the delivery device.The balloon was tightly folded and the stent was in the correct position on the balloon material.No damage or any issues were noted on the returned delivery device that could have contributed to the complaint incident.The stent was returned fully mounted onto the delivery system.A visual and microscopic examination identified a clear stringy foreign material intertwined around some stent struts approximately 4mm distal to the distal edge of the proximal markerband.The clear stringy foreign material was noted to be approximately 240mm in length.No issues were noted with the returned stent that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that a foreign matter was found stuck on the stent.The target lesion was located in the superior mesenteric artery.An 8.0x30x75cm express® ld iliac / biliary stent was selected for use to treat the lesion.However, it was noted that there was a string hanging off of the stent.The procedure was completed using a different device.No patient complications were reported.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7561184
• Report Number: 2134265-2018-04767
• Device Sequence Number: 16500021
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: 08714729579670
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 10/10/2019
• Device Model Number: H74938046830750
• Device Catalogue Number: 38046-83075
• Device Lot Number: 0019797476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR