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

Model Number	39202
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on device analysis completed on 03-dec-2018.It was reported that stent failure to deploy occurred.The target lesion was located in the severely tortuous and severely calcified iliac artery.A 10x100x75mm epic vascular stent was advanced for treatment.The thumbwheel was rotated by the prescribed method in order to deploy, but the outer sheath could not be pulled and the device was unable to be deployed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed outer sheath detachment from pull grip and stent partial deployment.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 that the outer sheath is detached from the pull grip.The rack is fully inside the handle so it is no longer visible.Microscopic examination revealed that the stent is partially deployed approximately 1mm from the middle sheath.There is blood present in the middle sheath and on the stent.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8165145
• Report Number: 2134265-2018-64070
• Device Sequence Number: 2879775
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: 08714729805113
• 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): 12/14/2018

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: 07/01/2022
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0020841003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1