MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number	39200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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.Visual and microscopic examination revealed no damages.The yellow lock is still in the manufactured position.The distal end of the middle sheath is still in contact with the proximal end of the tip.The stent is sticking out approximately 4.5mm from the distal end of the middle sheath.The rack measures approximately 6.1cm from the handle to the pull grip.There is blood present in the middle sheath and on the stent.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the stent inadvertently deployed.The presence of blood inside the device indicates this device was used in a procedure and likely entered the patient which is contrary to the reported information.There is no visible damage to the device that could have contributed to the stent being inadvertently deployed.The thumbwheel does not appear to have been unintentionally moved because the middle sheath is still in contact with the proximal end of the tip.Since the device appears to be used it is likely that the stent inadvertently deployed because of procedural factors.
Event or Problem Description
It was reported that the stent was inadvertently deployed.The target lesion was located at iliac artery.During preparation of a 12x40x75 epic vascular stent, it was noticed that the stent was already deployed.The thumbwheel lock had not been removed.The device was not used on the patient and the procedure was completed with a 6cm epic stent.There were no patient complications.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8509862
• Report Number: 2134265-2019-03791
• Device Sequence Number: 1633793
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: 08714729805151
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/12/2019

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: 09/27/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022718520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1