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	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter became stuck on the guidewire.The 100% stenosed target lesion was located in the severely tortuous and severely calcified left iliac artery.After the lesion was crossed with a non-boston scientific guidewire and pre-dilated with a balloon catheter, two different size epic stents were placed in advance.A 12x40x75mm epic vascular stent was then used for treatment, but because the device was not smooth enough from the time it was inserted from the sheath along the guidewire, the guidewire was moistened with heparinized saline solution.Since the system was able to advance to the target lesion, the stent was placed.The stent delivery system was tried to be remove leaving the guidewire and then continue post-dilation and intravascular ultrasound; however, it got stuck with the guidewire and had to remove the entire system.There were no patient complications reported.

• 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: 11649806
• Report Number: 2134265-2021-04033
• Device Sequence Number: 17104655
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: 08714729805151
• 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): 04/12/2021

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: 08/06/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024237514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 260 CM RADIFOCUS 0.035