MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200088020
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the lower extremity artery.An 8x80x120 epic¿ vascular stent was advanced but failed to cross the lesion.When the device was withdrawn, it was noted that the stent struts were lifted.The procedure was not completed as per patient's request.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.It was noticed the stent was partially deployed sticking out of the distal end approximately 7mm from the distal side of the markerband.There was damage noticed on the outer sheath of the device in the form of kinks and twisting.The damage was located at 9, 11,13.5 and 15cm from the proximal side of the markerband.Inspection of the remainder of the device revealed no other damage or irregularities. 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 damage occurred.The target lesion was located in the lower extremity artery.An 8x80x120 epic vascular stent was advanced but failed to cross the lesion.When the device was withdrawn, it was noted that the stent struts were lifted.The procedure was not completed as per patient's request.No patient complications were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7638089
• Report Number: 2134265-2018-05719
• Device Sequence Number: 16619108
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: 08714729805724
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2023
• Device Model Number: H74939200088020
• Device Catalogue Number: 39200-08802
• Device Lot Number: 0021740693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/15/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR