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

Model Number	39200
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that profile problem and hematoma occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified external iliac artery.A 7x40x75 epic vascular stent was advanced and deployed for treatment.However, the stent was suddenly shortened from the part where about 2cm was left.The lesion could not be covered and a hematoma developed on the peripheral side.Subsequently, a 7x80 stent was placed overlapping into the periphery from the first stent, and blood flow was able to be secured successfully.No patient complications nor injuries were reported.

• 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: 13860530
• Report Number: 2134265-2022-02491
• Device Sequence Number: 17466970
• Product Code: NIO
• UDI-Device Identifier: 08714729805458
• UDI-Public: 08714729805458
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2022

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: 10/12/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0026177319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER - MUSTANG 6.0-40; GUIDEWIRE - RADIFOCUS GW; INTRODUCER SHEATH - TERUMO 6F 10CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown