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

Model Number 39200

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  malfunction  

Event 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.

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 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
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8531830
• MDR Text Key: 142499489
• Report Number: 2134265-2019-04144
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805090
• UDI-Public: 08714729805090
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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