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

Model Number	H74939200101070
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: an epic self-expanding stent system was returned and the outer sheath, tip, and the remainder of the device were checked for damage.The device returned showing a partially deployed stent approximately 4.5cm from the markerband.No damage was noticed on the catheter shafts.Approximately 6.5cm of the stent was still contained inside of the mid-shaft.The thumbwheel was turned to try and deploy the rest of the stent to test functionality of the device.The stent deployed as designed.The customer stated that this was used in a tortuous anatomy, with this information it is not possible to replicate the clinical circumstances.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2017.It was reported that the stent would not deploy.A 10x100x75 epic vascular stent was selected for a biliary stenting procedure and it was reported that the stent would not deploy.The procedure was completed with another same device.No patient complications were reported and the patient's condition was good.However returned analysis revealed a partially deployed stent.

• 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: 6984592
• Report Number: 2134265-2017-10399
• Device Sequence Number: 684709
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: 08714729805113
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: 09/09/2017
• Device Model Number: H74939200101070
• Device Catalogue Number: 39200-10107
• Device Lot Number: 0017270278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR