MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number	39200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent was not visible under fluoroscopy.The 90% stenosed target lesion was located in the severely tortuousity and moderately calcified external iliac artery (eia) and common iliac artery (cia).Epic stents were placed in both eia and cia, but the one placed in cia did not appear on the cine cardioangiography.However, upon angiography by the physician, it was confirmed to be deployed and has been placed.The non-bsc diagnostic device placed in cia, in which epic body side was placed in eia could be confirmed by fluoroscopy.The epic in cia had thin rear marker, however it was able to be confirmed, but the marker strut at the tip almost could not be seen.The procedure was completed with this device with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an epic balloon catheter.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the inner line 11.1cm from the tip.Microscopic examination revealed no additional damages.There is blood present on and in the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported stent not visible under fluoroscopy since the stent was implanted.
Event or Problem Description
It was reported that stent was not visible under fluoroscopy.The 90% stenosed target lesion was located in the severely tortuousity and moderately calcified external iliac artery (eia) and common iliac artery (cia).Epic stents were placed in both eia and cia, but the one placed in cia did not appear on the cine cardioangiography.However, upon angiography by the physician, it was confirmed to be deployed and has been placed.The non-bsc diagnostic device placed in cia, in which epic body side was placed in eia could be confirmed by fluoroscopy.The epic in cia had thin rear marker, however it was able to be confirmed, but the marker strut at the tip almost could not be seen.The procedure was completed with this device with no patient complications reported.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8531830
• Report Number: 2134265-2019-04144
• Device Sequence Number: 11165793
• Product Code: NIO
• UDI-Device Identifier: 08714729805090
• UDI-Public: 08714729805090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 12/02/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023023386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: MUSTANG; BALLOON CATHETER: MUSTANG; GUIDE WIRE: RADIFOCUS; GUIDE WIRE: RADIFOCUS; INTRODUCER SHEATH: PARENT; INTRODUCER SHEATH: PARENT; BALLOON CATHETER: MUSTANG; GUIDE WIRE: RADIFOCUS; INTRODUCER SHEATH: PARENT