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

Model Number	39200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that inner shaft/sheath detachment occurred.Vascular access was obtained utilizing an ipsilateral femoral approach.The 90% stenosed target lesion was located in the moderately calcified common iliac artery.After a guide wire crossed the lesion, pre-dilatation was performed.A 7x40x75mm epic vascular stent was placed without problem.When the system was removed from the patient's body, the inner sheath was completely removed or pulled out from the outer of the device.No detachment occurred inside the patient's body.The device was originally had stopper applied but the stopper did not function.No patient complications were reported and the patient's status was good.
Event or Problem Description
It was reported that inner shaft/sheath detachment occurred.Vascular access was obtained utilizing an ipsilateral femoral approach.The 90% stenosed target lesion was located in the moderately calcified common iliac artery.After a guide wire crossed the lesion, pre-dilatation was performed.A 7x40x75mm epic vascular stent was placed without problem.When the system was removed from the patient's body, the inner sheath was completely removed or pulled out from the outer of the device.No detachment occurred inside the patient's body.The device was originally had stopper applied but the stopper did not function.No patient complications were reported and the patient's status was good.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.The inner liner was detached from the device.The inner liner showed kinks in 3 locations.The kinks were located at 3.5cm, 5cm and 6.5cm from the tip.The inner liner distal end damage looks like there may have been some tensile force applied due to the way the inner liner appears to be damaged and stretched.This damage is consistent with interference with the introducer sheath which may have caused the separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).

• 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: 7886384
• Report Number: 2134265-2018-61087
• Device Sequence Number: 11277975
• Product Code: NIO
• UDI-Device Identifier: 08714729805458
• UDI-Public: 08714729805458
• 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,Followup
• Report Date (Section B): 10/15/2018

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: 04/19/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022016627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1