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

Model Number 39200

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: visual examination of the returned device revealed multiple kinks to the sheath and the inner liner.The distal end of the middle sheath was no longer in contact with the proximal end of the tip.The lock was on the rack, and the rack measured 6.3cm from the handle to the pull grip.The stent was sticking out approximately 1mm from the distal end of the middle sheath.Inspection of the remainder of the device presented no other damages or irregularities.

Event Description

It was reported that inadvertent deployment occurred.A 12x40x75mm epic stent was selected however, part of the stent was exposed when it was removed from the packaging.When attempted to fix, the stent was inadvertently deployed.It was not used in patient.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8605839
• MDR Text Key: 144943400
• Report Number: 2134265-2019-05111
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: 08714729805151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022718299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1