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

Model Number	39200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	01/14/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that vessel perforation and bleeding occurred, and the patient died.The 100% stenosed, 8mm x 15 cm in length target lesion was located in the mildly tortuous and moderately calcified right iliac artery.An 8x60x75 and 10x80x75 epic vascular stents were advanced and implanted without issue.Post dilatation was then performed with an 8.0mmx60mmx135cm sterling balloon catheter; however, perforation was noted.The physician administered protamine to the patient.Hemostasis was then performed by dilatation for 80 minutes with the same balloon catheter and the device was able to stop the bleeding.On the following day, re-bleeding was noted, and 2 non-boston scientific stents were placed.Two days post procedure, the patient died.

• 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: 11267454
• Report Number: 2134265-2021-01085
• Device Sequence Number: 16958083
• Product Code: NIO
• UDI-Device Identifier: 08714729805694
• UDI-Public: 08714729805694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025480909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/02/2021
• 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: IMAGING CATHETER: CXI; INTRODUCER SHEATH: PARENT
• Outcome Attributed to Adverse Event: Death