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

Model Number	H74939200081020
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced cardiac arrest and hypotension requiring additional intervention.The patient underwent endovascular repair under local anesthesia.The 60% stenosed and occluded target lesion was located in the moderately tortuous and mildly calcified common iliac artery, external iliac artery, and mid to distal end superficial femoral artery.After gaining vascular access with a 5f femoral artery puncture sheath, a v-18 guidewire was advanced followed by placing a 6f 45cm sheath.Predilatation was performed using an 8x80 mustang balloon followed by advancing an 8x100x120 epic vascular self-expanding stent; however, resistance was felt during introduction and the stent could not reach the lesion site.During withdrawal, significant resistance was noted and the physician applied significant force.After removal, it was noted that the stent delivery shaft and the middle section of the stent was kinked which led to crossing failure.The patient is older and had suffered multiple underlying diseases, and at this point, the patient had a cardiac arrest due to drop in blood pressure.The physician carried out a series of first-aid compressions.The patient's heartbeat gradually revived, and the indicators slowly recovered.The stent implantation was suspended considering that the patient had underlying diseases, and the procedure had taken nearly three (3) hours.Patient was stable post procedure.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21211603
• Report Number: 2124215-2025-01010
• Device Sequence Number: 4045708
• Product Code: NIO
• UDI-Device Identifier: 08714729805564
• UDI-Public: 08714729805564
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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 Model Number: H74939200081020
• Device Catalogue Number: H74939200081020
• Device Lot Number: 0033490334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2025
• Initial Report FDA Received Date: 01/22/2025
• Date Device Manufactured: 02/23/2024
• 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: GUIDEWIRES: V18, STIFF HYDROPHILIC; SHEATH: 6F SHEATH
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG