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

Model Number	H74939200084020
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.An unspecified stent was selected for use during the procedure.However, it was noted that the distal tip of the device was damaged.The stent was then replaced with an 8x40x120 epic vascular stent; however, the device could not cross the lesion.Consequently, the procedure could not be completed.No patient injury was reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.An unspecified stent was selected for use during the procedure.However, it was noted that the distal tip of the device was damaged.The stent was then replaced with an 8x40x120 epic vascular stent; however, the device could not cross the lesion.Consequently, the procedure could not be completed.No patient injury was reported.It was further reported that two 8x40x120 epic vascular stents were used in the procedure, moreover, the patient was locally sedated when the issue occurred, and the device was removed using the normal method during the 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20708471
• Report Number: 2124215-2024-71564
• Device Sequence Number: 8211981
• Product Code: NIO
• UDI-Device Identifier: 08714729805649
• UDI-Public: 08714729805649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/04/2024

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: H74939200084020
• Device Catalogue Number: H74939200084020
• Device Lot Number: 0034436768
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 07/15/2024
• 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
• Patient Sex: Unknown