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

Model Number	H74939294601510
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent partially deployed and fractured within the patient, and an additional stent was required to treat the lesion.The 100% stenosed target lesion was located in the severely tortuous superficial femoral artery (sfa).A 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use to treat peripheral artery disease.During the procedure, the lesion was predilated, and the stent was advanced.Difficulty crossing the lesion was noted.When deployment was attempted, only about 3cm of the stent deployed.The remainder of the stent would not deploy.The thumbwheel stopped working, so the physician attempted to pull the handle and upon pulling back the pull grip, the stent snapped and the handle also snapped.The remaining portion of the stent was removed.An additional of two eluvia of the same size and a non-boston scientific stent was implanted at the site of the fractured stent to cover the portion of the stent that broke off.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the stent partially deployed and fractured within the patient, and an additional stent was required to treat the lesion.The 100% stenosed target lesion was located in the severely tortuous superficial femoral artery (sfa).A 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use to treat peripheral artery disease.During the procedure, the lesion was predilated, and the stent was advanced.Difficulty crossing the lesion was noted.When deployment was attempted, only about 3cm of the stent deployed.The remainder of the stent would not deploy.The thumbwheel stopped working, so the physician attempted to pull the handle and upon pulling back the pull grip, the stent snapped and the handle also snapped.The remaining portion of the stent was removed.An additional of two eluvia of the same size and a non-boston scientific stent was implanted at the site of the fractured stent to cover the portion of the stent that broke off.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the eluvia device was returned to our post market quality assurance laboratory.A visual and tactile examination identified an inner sheath kink 135mm proximal from the distal tip.A visual and tactile examination identified multiple outer sheath kinks.A visual and tactile examination identified that the inner sheath had separated from the device.Multiple inner sheath kinks was noted.The device was received with the stent already deployed from the delivery system.The deployed stent was not returned with the device.A visual examination identified no issues with the tip of the device.A visual examination identified that part of the luer on the handle was broke off and not returned with the device.This concludes the product analysis.

• 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: 23086407
• Report Number: 2124215-2025-64779
• Device Sequence Number: 10508328
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)270415(10)36479350
• 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,Followup
• Report Date (Section B): 12/05/2025

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: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0036479350
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown