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

Model Number	39200
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent shortened after deployment.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified subclavian artery which was very close to the aortic bifurcation.A 10x30x120cm epic vascular stent was advanced for treatment.Initially it was reported that when the stent was placed, nearly half of the stent came out from the subclavian artery to the aortic arch.Follow-up confirmed that there was no issue with the stent migrating, but there was a placement problem.The stent was short 3cm and the physician was unable to adjust the location.The stent was somehow brought up to the iliac artery and an express ld stent was placed over the epic stent.The express ld stent sufficiently extended up to external ilium and the epic stent was fixed in the iliac bifurcation.A 10x40mm epic stent was placed in the subclavian artery and the procedure was completed.No further patient complications were 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: 8025118
• Report Number: 2134265-2018-62496
• Device Sequence Number: 1030064
• Product Code: NIO
• UDI-Device Identifier: 08714729804987
• UDI-Public: 08714729804987
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 12/14/2021
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0020082240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: GUIDE WIRE: TREASURE FLOPPY 300; INTRODUCER SHEATH: TERUMO DESTINATION 90CM
• Outcome Attributed to Adverse Event: Required Intervention