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

Model Number	39202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified external iliac artery.A 7x100x75 epic vascular stent was advanced to treat the lesion.However, during procedure, the shaft broke and the stent could not be deployed since it was forced through severe calcification.The device was removed and came out normally and the procedure was completed with a different device.The stent was subsequently deployed outside the patient.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: theepic vascular 7x100x75 was received for analysis.The device was received with the stent fully deployed from the delivery system.The deployed stent was not returned for analysis.A visual and tactile examination found the inner shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified no issues with the handle of the device.
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified external iliac artery.A 7x100x75 epic vascular stent was advanced to treat the lesion.However, during procedure, the shaft broke and the stent could not be deployed since it was forced through severe calcification.The device was removed and came out normally and the procedure was completed with a different device.The stent was subsequently deployed outside the patient.There were no patient complications reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16593779
• Report Number: 2124215-2023-10905
• Device Sequence Number: 2906691
• Product Code: NIO
• UDI-Device Identifier: 08714729805557
• UDI-Public: 08714729805557
• 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,Followup
• Report Date (Section B): 04/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0026120563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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