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

Model Number	H74938046730750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 7.0x30x75cm express® ld iliac / biliary stent was advanced to treat the lesion.When the physician advanced the device through a sheath or a guide catheter, the stent came off the balloon.The physician attempted to snare the dislodged stent but the snaring device tangled in the stent.The patient then was taken to the operating room for a non-scheduled surgery to remove the dislodged stent.The stent was removed and a different stent was deployed.The procedure was then completed.No further patient complications were reported and the patient's status was okay.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the target lesion was located in the superior mesenteric artery.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: 7515286
• Report Number: 2134265-2018-04073
• Device Sequence Number: 14078729
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/19/2018

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: 07/03/2020
• Device Model Number: H74938046730750
• Device Catalogue Number: 38046-73075
• Device Lot Number: 0020845221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/06/2018
• 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
• Patient Age: 55 YR