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

Model Number	H74938046920750
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that the stent dislodged and migrated inside the patient requiring surgery.The target lesion was located in the right iliac artery.After a 7fr sheath was inserted, a 9.0x30x75cm express® ld iliac / biliary stent was advanced for treatment.However, during advancement through the stenosis, resistance was encountered.The physician attempted to pull the device back but the stent dislodged from the delivery system.Subsequently, the physician attempted to retrieve the dislodged stent with a snare but was unsuccessful and the stent migrated to the superficial femoral artery.The patient was then sent for surgery and the dislodged stent was removed by a vascular surgeon.No further patient complications were reported and the patient was in satisfactory condition, upon completion of the surgical procedure.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6756341
• Report Number: 2134265-2017-07622
• Device Sequence Number: 16403670
• Product Code: NIO
• UDI-Device Identifier: 08714729392316
• UDI-Public: (01)08714729392316(17)20190209(10)18908533
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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: 02/09/2019
• Device Model Number: H74938046920750
• Device Catalogue Number: 38046-92075
• Device Lot Number: 18908533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/01/2017
• 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