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

Model Number 39200

Device Problems Positioning Failure (1158); Difficult to Advance (2920)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that stent difficulty advancing and deployment difficulty occurred.The 75% stenosed target lesion was located in the severely tortuous iliac artery.A 8x80x75 epic vascular stent was advanced for treatment.However, during stent deployment, the thumbwheel was rotated, but marker on the outer shaft was not moving under fluoroscopy, and the stent could not be deployed.The rotation of the thumbwheel felt heavy, but it did not come off or break down.The resistance was stronger than usual because the meandering of the blood vessels was strong, and the placement of the stent was difficult.The use of the device was stopped, and it was removed from the sheath as it was.The procedure was completed with the balloon only and there were no patient complications nor injuries reported.However, returned device analysis revealed that the stent was partially deployed.

Manufacturer Narrative

Initial reporter address1: (b)(6).Initial reporter city: (b)(6).Device evaluated by mfr.: 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 that the stent is partially deployed 4.8cm from the distal end of the middle sheath.The shaft is damaged 13.5cm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15753280
• MDR Text Key: 307714793
• Report Number: 2124215-2022-43051
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805731
• UDI-Public: 08714729805731
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2022

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: 0026934409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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