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

Model Number	39200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent foreshortened.A 9mm x 80mm x 120cm epic self expanding stent was selected for use to treat a lesion in a non-tortuous right common iliac artery.During stent deployment, the stent foreshortened 20mm from its stated length.The procedure as completed without any patient complications.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the right common iliac artery.A 9x80x120 epic vascular stent was advanced for treatment.However, during procedure, it was noted that the stent seemed to foreshorten by at least 20 mm.There were no patient complications nor injuries reported.It was further reported that the device was not removed and the procedure was completed by using additional stent to cover the stenosed area.

• 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: 11306768
• Report Number: 2134265-2021-01370
• Device Sequence Number: 11584815
• Product Code: NIO
• UDI-Device Identifier: 08714729805861
• UDI-Public: 08714729805861
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 01/28/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025128962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/01/2021
• 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