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

Model Number	39200
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were removal difficulties and the patient experience pain.The target lesion was located in the biliary.A 10x80x75 epic vascular stent was advanced and placed for treatment.However, after positioning the stent in the lesion, the orange marker of shaft was stuck in the cell of the stent.When trying to move the shaft, the patient felt pain and so it was moved forward slowly from the patient's body and was successfully removed.There were no further patient complications and the patient was in good condition.
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.Visual examination revealed kinks to the inner liner 2.4cm, 6.2cm, and 11.1cm from the tip.The was a rub mark on the inner liner 1.7cm from the tip and stops at the first kink.The microscopic examination revealed damage to the proximal end of the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that there were removal difficulties and the patient experience pain.The target lesion was located in the biliary.A 10x80x75 epic vascular stent was advanced and placed for treatment.However, after positioning the stent in the lesion, the orange marker of shaft was stuck in the cell of the stent.When trying to move the shaft, the patient felt pain and so it was moved forward slowly from the patient's body and was successfully removed.There were no further patient complications and the patient was in good condition.

• 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: 9627930
• Report Number: 2134265-2020-00464
• Device Sequence Number: 16864509
• Product Code: NIO
• UDI-Device Identifier: 08714729805090
• UDI-Public: 08714729805090
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/23/2020

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: 07/27/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024177754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 03/23/2020
• 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: Other
• Patient Age: 78 YR