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

Model Number 20300

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The complaint device was not received at the complaint investigation site for analysis.Media was provided in the form of two photos.The first photo shows the distal end of the device, where the stent appears to be partially deployed and the inner liner kinked.The second photo shows the shelf box and part of the handle of the device.

Event Description

It was reported that the stent inadvertently deployed out of the sheath.The patient was being treated for vessel occlusion, and an 8x80x120 epic stent was selected for use.However, upon opening the package it was discovered the stent had slid off the catheter.Additional information from the field confirmed the packaging was intact with no damage.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that the stent inadvertently deployed out of the sheath.The patient was being treated for vessel occlusion, and an 8x80x120 epic stent was selected for use.However, upon opening the package it was discovered the stent had slid off the catheter.Additional information from the field confirmed the packaging was intact with no damage.The procedure was completed with another of the same device.There were no patient complications reported.The complaint device was not received at the complaint investigation site (cis) for analysis.Media was provided in the form of two photos.The first photo shows the distal end of the device, where the stent appears to be partially deployed and the inner liner kinked.The second photo shows the shelf box and part of the handle of the device.

Manufacturer Narrative

Correction: d4: lot number: updated from 0026916235 to 0032343536 d4: expiration date: updated from 03/03/2024 to 08/31/2026 d4: unique identifier (udi) #: updated from (b)(4) to (b)(4).H4: device manufacture date: updated from 03/04/2021 to 09/01/2023 h6: evaluation conclusion codes: updated from cause traced to transport/storage to unintended use error caused or contributed to event device evaluated by mfr: the epic device was received with the stent partially deployed on the delivery system.A visual examination identified no issues with the tip of the device.A visual and tactile examination of the inner sheath was noted to be kinked.A visual examination identified no issues or damage to the handle of the device.The safety lock was loosely in place on the handle of the device, which shows evidence that the safety lock was removed and replaced back on the device, during the procedure.Media was provided in the form of two photos.The first photo shows the distal end of the device.The stent appears to be partially deployed.The inner liner appears to be kinked.The second photo shows the shelf box and part of the handle of the device.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18924675
• MDR Text Key: 337913955
• Report Number: 2124215-2024-13565
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0032343536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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