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

Model Number	39200
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2022-43051
• Device Sequence Number: 2859119
• Product Code: NIO
• UDI-Device Identifier: 08714729805731
• UDI-Public: 08714729805731
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown