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

Model Number	39200
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 10x80x75 epic stent self expanding was advanced; however, resistance was felt and the device failed to cross the lesion.After removal, it was noted that the device was difficult to deploy and it was confirmed that the distal tip of the stent was crushed.The procedure was completed with another of same device.No patient complications nor injuries were 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: 11274551
• Report Number: 2134265-2021-01095
• Device Sequence Number: 4279994
• Product Code: NIO
• UDI-Device Identifier: 08714729805090
• UDI-Public: 08714729805090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 09/04/2022
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0021095314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1