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

Model Number	39200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 60% stenosed target lesion was located in a non-tortuous and non-calcified fistula of the left arm.A 8x40x75 epic vascular stent was advanced and deployed to treat the lesion.However, during removal, it was noticed that the inner white shaft was separated and was moving freely from the handle.The shaft did not dislodge entirely from the stent delivery system.The device was removed with ease and the procedure was completed.There were no patient complications.
Additional Manufacturer Narrative
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 inner liner is separated from the handle.The sheath is kinked 34cm and bent 3.5cm from the strain relief.There are multiple kinks to the inner liner.Microscopic examination revealed no additional damages.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The 60% stenosed target lesion was located in a non-tortuous and non-calcified fistula of the left arm.A 8x40x75 epic vascular stent was advanced and deployed to treat the lesion.However, during removal, it was noticed that the inner white shaft was separated and was moving freely from the handle.The shaft did not dislodge entirely from the stent delivery system.The device was removed with ease and the procedure was completed.There were no patient complications.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13559614
• Report Number: 2134265-2022-01126
• Device Sequence Number: 3818829
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: 08714729805656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 06/23/2026
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0027553566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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