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

Model Number	39202
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that shaft break occurred.Vascular access was obtained via the ipsilateral side.The 100% stenosed target lesion was located in the severely tortuous, and moderately calcified iliac artery.After a 0.014-inch guidewire was crossed, a 10x100x75 epic vascular stent was advanced for treatment.Meandering was very strong, and resistance was felt in advancing the stent into the lesion.An attempt was made to deploy the stent, but failed even after turning the wheel at about 20 ticks.The device was removed, but it was observed, that the outer shaft came off.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the ipsilateral side.The 100% stenosed target lesion was located in the severely tortuous and moderately calcified iliac artery.After a 0.014-inch guidewire was crossed, a 10x100x75 epic vascular stent was advanced for treatment.Meandering was very strong, and resistance was felt in advancing the stent into the lesion.An attempt was made to deploy the stent but failed even after turning the wheel at about 20 ticks.The device was removed, but it was observed that the outer shaft came off.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: epic vascular 10x100x75 was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.No issues were noted with the stent.The stent could not be deployed due to extensive damage to the sheath of the device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found the outer sheath of the device to be completely separated at the floating bumper.This type of damage is consistent with excessive tensile force being applied to the device.A visual and tactile examination found the inner shaft of the device to be severely kinked at more than one location.The inner sheath was also found to have severe stretching damage proximal of the outer sheath separation.This type of damage is consistent with excessive tensile force being applied to the device.No damage or issues were noted with the handle of the device.This concludes the product analysis.

• Brand Name: EPIC VASCULAR
• Common Device Name: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17073958
• Report Number: 2124215-2023-25053
• Device Sequence Number: 6673352
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: 08714729805113
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 03/24/2026
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0027035451
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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