MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200104070
Medical Device Problem Codes	Bent (1059); Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at the time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: 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.Various kinks were noticed on the inner liner approximately from the marker band to 7cm distal.The stent was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported deployment difficulty.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that deployment difficulties and stent damaged occurred.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified iliac artery.The 10x40x75mm was attempted to be deployed; however, the outer sheath became caught which resulted in damaging the epic¿ stent.The epic¿ was removed and the procedure was successfully completed with a 9x40mm epic¿ stent.No patient complications were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6629524
• Report Number: 2134265-2017-05716
• Device Sequence Number: 849444
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: (01)08714729805014(17)20211103(10)19927517
• Combination Product (Y/N): N
• 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): 05/19/2017

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: 11/03/2021
• Device Model Number: H74939200104070
• Device Catalogue Number: 39200-10407
• Device Lot Number: 19927517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1