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

Model Number	39201
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent foreshortening occurred.The target lesion was located in the distal superficial femoral artery (sfa).A 6 x 120 x 120 mm epic stent was advanced for treatment.However, during deployment, stent foreshortening about 2-3 cm from the proximal finishing segment of the lesion was observed.It was determined by marked screen for placement and estimated by the physician under fluoroscopy.Another 6x40 epic stent was pulled out to cover the area that was missed.Following post dilatation, the stent was well positioned, apposed and fully expanded and the procedure was completed.The patient was discharged with no patient complications reported and the patient's status was fine.

• 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: 7855102
• Report Number: 2134265-2018-60665
• Device Sequence Number: 1431508
• Product Code: NIO
• UDI-Device Identifier: 08714729805229
• UDI-Public: 08714729805229
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 08/14/2022
• Device Model Number: 39201
• Device Catalogue Number: 39201
• Device Lot Number: 0021012635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/07/2018
• 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