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

Model Number 39200

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

It was reported that there was a difficulty in removing the device occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified external iliac artery.A 9x80x75 epic vascular stent was used for treatment.However, when the wheel was rotated to check if it can be deployed, resistance was felt due to the calcified lesion during both removal and insertion.Physician was able to remove the device, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• Brand Name: EPIC VASCULAR
• 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: 17927317
• MDR Text Key: 325604057
• Report Number: 2124215-2023-52670
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805878
• UDI-Public: 08714729805878
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

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 Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0028696705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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