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

Model Number	H74939294601210
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system was difficult to remove.This 6x120, 130 cm eluvia self expanding stent was selected for use during a procedure to treat a 70% stenosed, mildly calcified, severely tortuous superficial femoral artery lesion.During the procedure, the lesion was predilated using a 6mm balloon.After the stent had been properly flushed and prepared, difficulty was noted when advancing the stent catheter over the non-boston scientific guidewire when placing across the lesion.Extra force was needed for placement, and the stent was deployed without issue; however, the delivery system was difficult to remove.The blue handle was broken off to make it easier to walk back over the wire; however, it was still difficult, and after approximately 10mm, the whole system became stuck on the wire.The system was removed along with the wire and lesion access was regained to complete the procedure.It was noted that the aorta bifurcation was very tortuous and may have caused some of the difficulty to advance.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the delivery system was difficult to remove.This 6x120, 130 cm eluvia self expanding stent was selected for use during a procedure to treat a 70% stenosed, mildly calcified, severely tortuous superficial femoral artery lesion.During the procedure, the lesion was predilated using a 6mm balloon.After the stent had been properly flushed and prepared, difficulty was noted when advancing the stent catheter over the non-boston scientific guidewire when placing across the lesion.Extra force was needed for placement, and the stent was deployed without issue; however, the delivery system was difficult to remove.The blue handle was broken off to make it easier to walk back over the wire; however, it was still difficult, and after approximately 10mm, the whole system became stuck on the wire.The system was removed along with the wire and lesion access was regained to complete the procedure.It was noted that the aorta bifurcation was very tortuous and may have caused some of the difficulty to advance.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, a visual and tactile examination identified multiple inner sheath kinks and an outer sheath kink 2mm distal from the distal end of the nose cone.The investigator was unable to advance a guidewire through the device due to the damage noted to the inner/outer sheath.The guidewire used by the customer was not returned for analysis.The device was received with the stent already deployed from the delivery system.A visual examination identified no issues with the tip of the device.A visual examination identified no issues or damage to the handle of the device.A break in the pull grip handle was noted.

• 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: 22214590
• Report Number: 2124215-2025-35183
• Device Sequence Number: 12926528
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)260919(10)35049392
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/30/2025

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 Expiration Date: 09/19/2026
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0035049392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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