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

Model Number 20300

Device Problems Difficult to Insert (1316); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

It was reported the stent inadvertently deployed.A 9x60x120 epic was selected for a procedure in the iliac artery.It was difficult to get the epic through the non-boston scientific 6fr sheath.Upon review, it was found that the tip of the stent was partly deployed.The procedure was completed with a different stent.There were no patient complications and the patient was in good condition.

Manufacturer Narrative

Device evaluated by manufacturer: 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 kinks to the sheath at 3.5cm, 104cm, and 112.7cm from the nosecone.The stent is partially deployed approximately 2mm from the distal end of the sheath.Microscopic examination revealed no additional damages.

Event Description

It was reported the stent inadvertently deployed.A 9x60x120 epic was selected for a procedure in the iliac artery.It was difficult to get the epic through the non-boston scientific 6fr sheath.Upon review, it was found that the tip of the stent was partly deployed.The procedure was completed with a different stent.There were no patient complications and the patient was in good condition.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10826112
• MDR Text Key: 215918574
• Report Number: 2134265-2020-15742
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0025746172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO 6FR SHEATH.; TERUMO 6FR SHEATH.