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

Model Number	H74939200126070
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.The device was not returned for analysis.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 the stent delivery system (sds) became stuck on the guidewire.An ipsilateral retrograde approach was used to access the 99% stenosed target lesion located in the moderately tortuous and moderately calcified common iliac artery (cia).A 12x60x75 epic¿ vascular stent and 0.035 non-bsc guidewire were selected for use.When the stent was directly advanced to the lesion, the sds became stuck midway and could not cross the lesion.The sds and wire were removed together.The devices were checked outside the body and there was some "unusual feeling in the passability".A new wire and a 12x60x120 epic stent were used to complete the procedure.Post dilation was performed and good vascular patency was observed.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7041565
• Report Number: 2134265-2017-11076
• Device Sequence Number: 19342280
• Product Code: NIO
• UDI-Device Identifier: 08714729805199
• UDI-Public: 08714729805199
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: H74939200126070
• Device Catalogue Number: 39200-12607
• Device Lot Number: 0020050440
• 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