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

Model Number	H74939294601510
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, including device lot number, but further information was unable to be obtained.
Event or Problem Description
It was reported that the stent was not adequately apposed to the vessel wall, resulting in occlusion and additional intervention.An eluvia us, 6x150, 130 cm was selected for use.The patient was implanted with the eluvia in (b)(6) 2024.On (b)(6) 2025, the patient presented with recurring symptoms.It was revealed that the eluvia was completely occluded.Imaging revealed that the stent was not apposed correctly to the vessel wall.The apposition issues were not evident on angiography at the time the stent was placed.To treat the event, an additional stent was placed to cover the abnormal portion of the eluvia.

• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21658127
• Report Number: 2124215-2025-17033
• Device Sequence Number: 8940034
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• 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: 2024
• 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): 03/20/2025

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
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/20/2025
• 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