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

Model Number	39202
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac to external iliac artery.Following pre-dilation with a balloon catheter, a 7x100x75mm epic stent was advanced to treat the lesion.However, during deployment, it was noted that the stent was elongated.The device was removed together with the sheath and fluoroscopic images was performed, there was no segment or part of the device remained inside the patient's body.The procedure was completed with a non-bsc 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: 8209440
• Report Number: 2134265-2018-64680
• Device Sequence Number: 10832151
• Product Code: NIO
• UDI-Device Identifier: 08714729805557
• UDI-Public: 08714729805557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 10/08/2022
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0021232060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: INTRODUCER SHEATH: MEDIKIT SUPER SHEATH 6FR 11CM