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

Model Number	H74938047730130
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the left subclavian artery.A 7.0x30x135cm express® ld iliac / biliary stent was advanced to treat the lesion.However, during advancement, the stent came off the balloon.The device was pulled out and the stent was removed with a snare.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was returned for analysis.The stent was detached from the balloon.Stent damage was noted along the entire length of the stent with stent struts squashed mostly at one end and mid-section of the stent.The balloon did not appear to have been subjected to any positive pressure.As part of the device analysis, the device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure with no leaks or restrictions noted.The balloon deflated within 12.5 seconds with no issues noted.A visual and tactile examination identified no issues along the length of the device.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 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 stent dislodgment occurred.The target lesion was located in the left subclavian artery.A 7.0x30x135cm express® ld iliac / biliary stent was advanced to treat the lesion.However, during advancement, the stent came off the balloon.The device was pulled out and the stent was removed with a snare.The procedure was completed with a different device.No 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: 6256010
• Report Number: 2134265-2016-12490
• Device Sequence Number: 1026005
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: (01)08714729579694(11)20190804(10)0019552977
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/19/2016

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: 08/04/2019
• Device Model Number: H74938047730130
• Device Catalogue Number: 38047-73013
• Device Lot Number: 0019552977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/13/2017
• 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
• Patient Age: 56 YR