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

Model Number	H74939200088020
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
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 the stent was protruding.An epic¿ vascular stent 8x80x120 was selected for a percutaneous transluminal angioplasty (pta) procedure in the iliac vein for a moderately calcified lesion with 99% stenosis.During unpacking, it was noted that the stent was protruding from the sheath.
Additional Manufacturer Narrative
Returned product consisted of an epic self-expanding stent system.The outer sheath, tip, and the remainder of the device were checked for damage.No damage was noticed on the device.The stent was inadvertently partially deployed approximately 4.5mm from the marker band.Inspection of the remainder of the device, 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 considered handling damage as the event occurred prior to patient contact.(b)(4).
Event or Problem Description
It was reported that the stent was protruding.An epic¿ vascular stent 8x80x120 was selected for a percutaneous transluminal angioplasty (pta) procedure in the iliac vein for a moderately calcified lesion with 99% stenosis.During unpacking, it was noted that the stent was protruding from the sheath.

• 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: 6580775
• Report Number: 2134265-2017-04926
• Device Sequence Number: 95665
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: (01)08714729805724(17)20180731(10)18233221
• 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,Followup
• Report Date (Section B): 04/28/2017

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: 07/31/2018
• Device Model Number: H74939200088020
• Device Catalogue Number: 39200-08802
• Device Lot Number: 18233221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1