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

Model Number	H74939200071070
Medical Device Problem Codes	Bent (1059); Device Slipped (1584); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event: 18 years of age or older (b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
It was reported there was positioning placement issues which caused the stent to deploy prematurely with profile problems.The physician was performing a stenting treatment procedure in a 90% stenosed, approximately 6mm, moderately tortuous, mildly calcified bifurcation between the internal iliac artery and external iliac artery.During the advancement of the 7x100x75 epic vascular stent, the delivery system "jumped" past the intended deployment site and was unintentionally partially deployed.The stent was pushed and shortened from 10cm to 4cm.The physician implanted another 7x80 epic stent to complete the procedure with no further complications and no reported injury to the patient.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7042189
• Report Number: 2134265-2017-11086
• Device Sequence Number: 1399090
• Product Code: NIO
• UDI-Device Identifier: 08714729805557
• UDI-Public: 08714729805557
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 05/24/2022
• Device Model Number: H74939200071070
• Device Catalogue Number: 39200-07107
• Device Lot Number: 0020690166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/17/2017
• 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