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

Model Number	H74939200106070
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that deployment issue occurred.During preparation of a 10x60x75 epic¿ vascular stent, upon removal of the device from its case, it was noted that the stent marker part protruded from the distal tip.The yellow lock of the grip was connected and no dial operation was performed.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
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 on the shaft.The stent was partially deployed approximately.4mm 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 considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that deployment issue occurred.During preparation of a 10x60x75 epic¿ vascular stent, upon removal of the device from its case, it was noted that the stent marker part protruded from the distal tip.The yellow lock of the grip was connected and no dial operation was performed.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6304176
• Report Number: 2134265-2017-00397
• Device Sequence Number: 500657
• Product Code: NIO
• UDI-Device Identifier: 08714729805052
• UDI-Public: (01)08714729805052(17)20210126(10)0018858729
• 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): 01/10/2017

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: 01/26/2021
• Device Model Number: H74939200106070
• Device Catalogue Number: 39200-10607
• Device Lot Number: 0018858729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1