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

Model Number	H74939294701510
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	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partial deployment occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified peripheral artery via contralateral femoral approach with through and through access to tibial vessel.A 7x150,130cm eluvia stent was selected for use.During the procedure, the stent deployed about 100cm and then failed.The handle broke apart to reveal catheters underneath to pin and pull and had to straighten the catheters that had coiled under the thumbwheel.Consequently, the stent became stretched or elongated.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6 - evaluation conclusion codes: updated.
Event or Problem Description
It was reported that the stent partial deployment occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified peripheral artery via contralateral femoral approach with through and through access to tibial vessel.A 7x150,130cm eluvia stent was selected for use.During the procedure, the stent deployed about 100cm and then failed.The handle broke apart to reveal catheters underneath to pin and pull and had to straighten the catheters that had coiled under the thumbwheel.Consequently, the stent became stretched or elongated.The procedure was completed with another of same device.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: 23851304
• Report Number: 2124215-2025-92039
• Device Sequence Number: 18502978
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: (01)08714729876748(17)270523(10)36832475
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/05/2026

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 Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0036832475
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 05/23/2025
• 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