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

Model Number	H74939200124070
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an epic self-expanding stent system.The device did show a.035 guidewire was in the device upon return.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.The outer shaft showed no damage.The guidewire that was in the device was pulled from the device with no hesitations or restrictions.The complaint of the guidewire being stuck was not confirmed.Inspection of the remainder of the device, revealed no damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
Same case as mdr 2134265-2017-11938.It was reported the catheter was stuck on the wire.A 12x40x75 epic¿ vascular stent was selected for a aortagram with runoff procedure in the common iliac artery.The stent was deployed successfully.Upon removing the stent from the.035 amplatz wire, the stent catheter was stuck to the guidewire.The wire and device were all removed together as one unit.There were no patient complications reported and the patient's status post procedure was reported as ok.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7049149
• Report Number: 2134265-2017-11355
• Device Sequence Number: 1260047
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: 08714729805151
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 06/21/2022
• Device Model Number: H74939200124070
• Device Catalogue Number: 39200-12407
• Device Lot Number: 20802617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR