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

Model Number	H74938046920750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the left common iliac artery.A 9.0x30x75cm stent was advanced but device was unable to cross through a previously implanted stent.The physician attempted to push the device through the previously implanted stent and device got caught with implanted stent then the stent started to slide off the balloon.The device was removed and the physician decided to re-introduce the same device.After the device would not cross the affected lesion, the physician tried to pull the device out of the patient's body but the device got caught on the sheath and the stent completely slid off the balloon.An attempt to remove the dislodged stent was made but was unsuccessful.The balloon was then re-inserted into the lumen of the dislodged stent and deployed in a different section in the iliac artery.A non-bsc stent was advanced but still failed with the same result.It was further reported that the procedure was completed successfully.No further 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 - GALWAY
• MDR Report Key: 6997626
• Report Number: 2134265-2017-10805
• Device Sequence Number: 1184636
• Product Code: NIO
• UDI-Device Identifier: 08714729392316
• UDI-Public: 08714729392316
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: H74938046920750
• Device Catalogue Number: 38046-92075
• Device Lot Number: 0019008673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention