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

Model Number	39200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that sheath detachment occurred.A 9x60x120mm and a 9x60x75mm epic iliac stents were successfully deployed.However, during removal of the stent from the sheath, the physician noticed that the inner sheath on one was intact and still on the wire and was removed over the wire from the body.The second one was intact and was removed from the body as one piece.It was noticed after removal that it was starting to separate.There were no patient complications reported.
Event or Problem Description
It was reported that sheath detachment occurred.A 9x60x120mm and a 9x60x75mm epic iliac stents were successfully deployed.However, during removal of the stent from the sheath, the physician noticed that the inner sheath on one was intact and still on the wire and was removed over the wire from the body.The second one was intact and was removed from the body as one piece.It was noticed after removal that it was starting to separate.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated mfr.: the epic was returned to boston scientific for analysis.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.The device batch number is a match to the complaint batch number.Visual examination showed the inner sheath had completely separated.The guidewire was not returned.The stent had deployed and was not returned.The rack was fully retracted.The outer shaft had one kink visible 2.8 cm from the pull grip tip.The inner sheath had one kink 7.8 cm from the distal tip.The proximal end of the inner sheath showed no damage.X-ray examination of the handle showed no issues.The handle was disassembled, and the flow restrictor was examined.No damage to the flow restrictor and the inner sheath moved through the flow restrictor with no issue.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: 14940822
• Report Number: 2134265-2022-07210
• Device Sequence Number: 4583333
• Product Code: NIO
• UDI-Device Identifier: 08714729805823
• UDI-Public: 08714729805823
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/23/2022

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: 0026934413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/23/2022
• 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: Male