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

Model Number	39200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial facility reporter name: (b)(6).Initial reporter city: (b)(6).
Event or Problem Description
It was reported that removal difficulty occurred.Vascular access was obtained via upper arm approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right iliac artery.A 10 x 60 x 120 epic vascular stent was advanced for treatment.After treating the distal part with the 0.014 system, it was replaced with a 0.035 non-bsc guidewire.Upon removal of the stent delivery system after stent implantation, the guidewire and epic system was stuck.The entire system was replaced and a new guidewire was then re-inserted.The stent was post dilated with a balloon to complete the procedure.There was no problem with the patient, and there was no health damage to the patient.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12197192
• Report Number: 2134265-2021-09204
• Device Sequence Number: 3590622
• Product Code: NIO
• UDI-Device Identifier: 08714729805045
• UDI-Public: 08714729805045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 02/04/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025169577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1