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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent prematurely deployment occurred.An 8x60x75 epic stent was selected for use for a patient procedure.However, resistance was felt when inserting the stent and when removed, the tip of the stent was found to be deployed for about 1mm.The stopper of the handle part was not released, so an issue of the device occurred during unpacking might be possible.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) hospital.(b)(6).Device evaluated by mfr.: the epic was returned to boston scientific for analysis.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination showed a kink 6.5 cm from the distal end of the sheath.Microscopic examination revealed 1mm partial deployment of the stent.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that stent premature deployment occurred.An 8x60x75 epic stent was selected for use for a patient procedure.However, resistance was felt when inserting the stent and when removed, the tip of the stent was found to be deployed for about 1mm.The stopper of the handle part was not released, so an issue of the device occurred during unpacking might be possible.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12059001
• MDR Text Key: 258109987
• Report Number: 2134265-2021-07840
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: 10/09/2022
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0024575142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS