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

Model Number	39200
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05dec2022.It was reported that crossing difficulties and shaft kink were encountered.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified iliac artery.A 10x60x120 epic vascular stent was advanced for treatment.However, during the procedure, it failed to cross the lesion and a shaft kinked was noticed post procedure.The procedure was completed with a 10x40x120 epic stent.No patient complications were reported and the patient was fine.However, returned device analysis revealed stent damage.
Additional Manufacturer Narrative
Device evaluated by mfr: epic vascular 10x60x120 was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.The stent was kinked at more than one location on the delivery system.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no issues with the tip of the device.A visual and tactile examination found shaft of the device to be kinked at the same location where the mounted stent is kinked on the delivery system.This type of damage is consistent with excessive force being applied to the device.

• 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: 16008670
• Report Number: 2124215-2022-51998
• Device Sequence Number: 6570361
• Product Code: NIO
• UDI-Device Identifier: 08714729805045
• UDI-Public: 08714729805045
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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: 05/06/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025497748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• 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