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); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation occurred in the right external iliac.A 9mm x 40mm epic stent, a 7mm x 60mm eluvia stent and 7mm x 40mm mustang were selected for the treatment of peripheral vascular disease in the external iliac.The lesion was pre-dilated with a 5mm x 100mm mustang balloon followed by an arteriogram to mark the landing zones.A 9mm x 40mm epic stent and a 7mm x 60mm eluvia stent were placed to treat the lesion.Post dilation was performed with a 7mm x 40mm mustang.The certified rn anesthetist noticed changes in the patient's carbon dioxide levels and blood pressure.Repeat arteriograms were performed reveling a perforation in the right external iliac.Hypotension and blood loss were reported as a result of the perforation.It was thought that the perforation possibly occurred during post dilation of the stents and calcification of the lesion contributed to the perforation.The perforation was treated using a non-boston scientific stent and multiple long balloon inflations.There were no patient complications reported after the perforation was treated.The patient was stable after the procedure.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12802589
• Report Number: 2134265-2021-13997
• Device Sequence Number: 5484596
• Product Code: NIO
• UDI-Device Identifier: 08714729805793
• UDI-Public: 08714729805793
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 05/18/2026
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0027340789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Race: Black Or African American