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	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) medical center.
Event or Problem Description
It was reported that stent damage occurred.The patient underwent endovascular therapy (evt) of the 90% stenosed target lesion located in the moderately tortuous and mildly calcified common iliac artery (cia) to external iliac artery (eia).An 8x100x120 epic vascular stent was advanced for treatment using an approach from the upper extremities.However, a residual stenosis was observed at the origin of the cia which was treated with an 8.0x40x135 cm express ld vascular stent and completing the procedure.Fifteen days later, claudication symptoms recurred, and the patient visited the clinic for an outpatient consultation.The evt was therefore re-performed as thrombus occlusion was suspected based on echocardiographic findings.Angiography confirmed that the express ld vascular stent had flattened causing vessel occlusion and obstructed blood flow.After crossing the guidewire into the flattened stent, a 10x40x120 epic vascular stent was implanted from the inside of the express ld stent to confirm expansion.The procedure was completed.2 weeks later, fluoroscopy revealed that the express ld and 10x40x120 epic vascular stents had also flattened in the same way.However, no recurrence of symptoms was observed at that time.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19074179
• Report Number: 2124215-2024-17458
• Device Sequence Number: 6900382
• Product Code: NIO
• UDI-Device Identifier: 08714729805007
• UDI-Public: 08714729805007
• 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: 2024
• 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): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0032322197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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
• Patient Sex: Unknown