MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA?; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	H74939294601510
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that partial stent deployment occurred, and the stent stretched.The 30% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery and accessed via antegrade approach.A 6mm x 150mm ,130cm eluvia? self-expanding stent was selected for use.During the procedure, only 95% (approximately 145mm) of the stent was deployed, and the final 5mm of the stent could not be deployed.The pull grip would not work, so the stent was manually deployed by breaking open the handle and pulling the catheter.The stent was implanted but stretched some.The delivery catheter was removed, a mustang balloon catheter was used to post dilate, and the procedure was completed.It was noted that the procedure was prolonged, but there were no patient complications as a result of this event.

• Brand Name: ELUVIA?
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 23711323
• Report Number: 2124215-2025-85686
• Device Sequence Number: 18801926
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)270723(10)37219045
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0037219045
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 07/23/2025
• 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