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

Model Number	39200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.Vascular access was obtained utilizing a contralateral approach.The 90% stenosed target lesion was located in the severely tortuous and calcified external iliac artery.A 8x60x120 epic stent was advanced for treatment.The physician advanced the device to the lesion and initiated the deployment of the stent.During deployment the stent dislodged in the aorta ventralis.An additional stent was then placed in the aorta ventralis.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 9617205
• Report Number: 2134265-2020-00378
• Device Sequence Number: 2721224
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: 08714729805687
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023644141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR