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

Model Number	H74939200086020
Medical Device Problem Codes	Premature Activation (1484); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 8x60x120 epic¿ vascular stent was selected to treat the lesion.Predilation was performed, however during preparation of the device, it was noted that the top of the stent was shifted.The device was not used and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.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.A kink was noted on the shaft approximately 8.5 cm from the tip.The stent was inadvertently deployed approximately.9 mm from the marker band.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink was attributable to handling of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 8 x 60 x 120 epic vascular stent was selected to treat the lesion.Predilation was performed, however during preparation of the device, it was noted that the top of the stent was shifted.The device was not used and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 6285835
• Report Number: 2134265-2017-00343
• Device Sequence Number: 16433987
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: (01)08714729805687(17)20190228(10)18926446
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 01/09/2017

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: 02/28/2019
• Device Model Number: H74939200086020
• Device Catalogue Number: 39200-08602
• Device Lot Number: 18926446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1