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	01/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial inadvertent deployment occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified iliac artery.During unpacking of a 8x40x120 epic stent, it was noted that the tail end of the stent had deployed 0.5cm.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient status was stable.
Additional Manufacturer Narrative
Device was 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.Visual examination revealed that the stent was partially deployed 5mm from the distal end of the middle sheath.The tip was slightly bent.The microscopic examination revealed damage to the proximal end of the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that stent partial inadvertent deployment occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified iliac artery.During unpacking of a 8x40x120 epic stent, it was noted that the tail end of the stent had deployed 0.5cm.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient status was stable.

• 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: 9676747
• Report Number: 2134265-2020-01009
• Device Sequence Number: 2469484
• Product Code: NIO
• UDI-Device Identifier: 08714729805649
• UDI-Public: 08714729805649
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/23/2020

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: 05/20/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023837248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR