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

Model Number	H74938046830750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The 90% stenosed target lesion was located in the right external iliac artery.Following pre-dilatation, a 8.0x30x75cm express® ld iliac / biliary stent was advanced but failed to cross the lesion.However, when the device was removed, the stent came off.The stent was retrieved by snaring and device was completely removed from the patient.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was further reported that the target lesion was located in the non-tortuous and mildly calcified right external iliac artery.
Additional Manufacturer Narrative
Describe event or problem, device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: a visual and microscopic examination was performed on the returned stent, the following attributes were examined: the delivery system was not returned for analysis.The detached stent was received attached to the snare which was still within the customer's guide catheter.Due to the condition of the stent it was not possible to remove it from the snare or the guide catheter.A visual and microscopic examination was performed on the detached stent.The stent was severely damaged and compressed along its entire length.No issues were noted with the stent that couldn¿t 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 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).

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7388600
• Report Number: 2134265-2018-02538
• Device Sequence Number: 16202846
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: 08714729579670
• 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): 03/09/2018

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: 06/08/2020
• Device Model Number: H74938046830750
• Device Catalogue Number: 38046-83075
• Device Lot Number: 0020748973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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: 83 YR