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

Model Number	H74939200084070
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).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 guide wire returned was stuck in the device and sticking out of the distal end 227cm from the tip.It was noticed the stent was partially deployed sticking out of the distal end approximately 3cm.There was no damage noticed on the outer sheath of the device; however, there was damage on the inner sheath approximately 4.3cm from the tip in the form of buckling.The device was x-rayed to see internally if any damage was causing the guide wire to stick.There was no damage noticed.Upon further investigation it was noticed that the buckling on the inner sheath was constricting around the guide wire which was causing it to stick in the device.The guide wire was pulled to try and remove it but it would not exit the device.Inspection of the remainder of the device, revealed no other damage or irregularities.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.The target lesion was located in the moderately calcified left iliac artery to the aorta.After a guide wire was advanced, a 8x40x75mm epic¿ vascular stent was selected for use to treat the lesion and in the part that was not sufficiently dilated.However, the device was unable to advance outside the body midway of the guide wire and it got stuck.When the device was pushed strongly, the stent was deployed at about 2 cm from the tip of the shaft.The device was removed together with the guide wire and the procedure was completed with another 9x40mm epic¿ vascular stent.No patient complications nor injuries were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7473633
• Report Number: 2134265-2018-03616
• Device Sequence Number: 16447972
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: 08714729805656
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 05/11/2022
• Device Model Number: H74939200084070
• Device Catalogue Number: 39200-08407
• Device Lot Number: 20636698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: EGOIST; INTRODUCER SHEATH: TERUMO