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

Model Number	H74939200078070
Medical Device Problem Codes	Bent (1059); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was not received for analysis.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 damage occurred.The 99% stenosed and moderately tortuous target lesion was located in the upper arm.Percutaneous transluminal angioplasty was being performed; an unknown manufacturer¿s guidewire crossed the lesion via the veinous antegrade approach.Pre-dilation was performed with a non bsc balloon catheter, however, dilation was not satisfactory and a 7x80x75mm epic¿ vascular stent was advanced.During deployment of the epic¿ stent, the physician experienced deployment difficulty in the handle's deployment dial.The stent opened 2-3cm from the tip and the physician then deployed the stent with tension by pulling.The stent deployed with about 2 struts bent inward.Angiography was performed and flow was limited, subsequently a non bsc balloon catheter was delivered but it was unable to pass through the epic¿ vascular stent.Dilation was then performed inside the epic¿ vascular stent with another non bsc balloon catheter.Stent in stent placement was performed using a 6x24mm wallstent.Flow was recovered following post dilation and the procedure was completed.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: 6540866
• Report Number: 2134265-2017-04135
• Device Sequence Number: 16331145
• Product Code: NIO
• UDI-Device Identifier: 08714729805533
• UDI-Public: (01)08714729805533(17)20211109(10)0019949685
• Combination Product (Y/N): N
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 11/09/2021
• Device Model Number: H74939200078070
• Device Catalogue Number: 39200-07807
• Device Lot Number: 0019949685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/03/2017
• 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: Required Intervention