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

Model Number	H74939200086020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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.No damage was noticed.The stent was inadvertently deployed approximately.8mm from the marker band.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 13jan2017.It was reported that the stent failed to deploy.A 8x60x120 epic¿ vascular stent was advanced to treat the lesion.However, the stent could not be released by pull grip.The device was removed from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However returned device analysis revealed that the stent was inadvertently deployed.

• 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: 6305789
• Report Number: 2134265-2017-00443
• Device Sequence Number: 310564
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: (01)08714729805687(17)20190228(10)18905460
• 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): 01/13/2017

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: 18905460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1