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

Model Number	H74939294700410
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that premature deployment occurred.The stenosed target lesion was located in the left superficial femoral artery.A 7x40, 130 cm eluvia stent was delivered through a.035 amplatz guidewire via contralateral approach to overlap and extend length of previously deployed stent.However, prior to reaching the target lesion and removing the yellow safety lock mechanism, the stent deployed prematurely.An attempt was made to deploy a non-boston scientific stent, but unsuccessful in reaching the target location.The physician decided against pursuing any further intervention and chose not to deploy a stent, ending the case.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that premature deployment occurred.The stenosed target lesion was located in the left superficial femoral artery.A 7x40, 130 cm eluvia stent was delivered through a.035 amplatz guidewire via contralateral approach to overlap and extend length of previously deployed stent.However, prior to reaching the target lesion and removing the yellow safety lock mechanism, the stent deployed prematurely.An attempt was made to deploy a non-boston scientific stent, but unsuccessful in reaching the target location.The physician decided against pursuing any further intervention and chose not to deploy a stent, ending the case.There were no patient complications as a result of this event.It was further reported that the previously deployed 7x120 eluvia was not long enough to cover entirety the lesion, which is why the 7x40 was used.

• 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: 24003824
• Report Number: 2124215-2026-01232
• Device Sequence Number: 10398880
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: (01)08714729876694(17)260905(10)35031281
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 01/28/2026

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: 09/05/2026
• Device Model Number: H74939294700410
• Device Catalogue Number: H74939294700410
• Device Lot Number: 0035031281
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 09/05/2024
• 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