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 Codes	Pain (1994); Discomfort (2330)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partial deployment and damage occurred, resulting in additional intervention.The 80 % stenosed target lesion was located in the severely tortuous and mildly calcified superficial femoral artery.A 7x150, 130 cm eluvia was selected for use.During the procedure, upon stent deployment using the turn wheel, the turn wheel failed to retract the deployment sheath halfway through.The stent was deployed 50 cm out of 150cm.The physician had to pull the delivery system, which elongated the stent approximately 100cm, requiring additional intervention.The device was pulled out of the body, and an additional angioplasty was performed.It was noted that the patient experienced discomfort and pain; however, the patient condition was stable after the procedure.
Event or Problem Description
It was reported that stent partial deployment and damage occurred, resulting in additional intervention.The 80 % stenosed target lesion was located in the severely tortuous and mildly calcified superficial femoral artery.A 7x150, 130 cm eluvia was selected for use.During the procedure, upon stent deployment using the turn wheel, the turn wheel failed to retract the deployment sheath halfway through.The stent was deployed 50 cm out of 150cm.The physician had to pull the delivery system, which elongated the stent approximately 100cm, requiring additional intervention.The device was pulled out of the body, and an additional angioplasty was performed.It was noted that the patient experienced discomfort and pain; however, the patient condition was stable after the procedure.
Additional Manufacturer Narrative
H6 - evaluation method codes and evaluation conclusion codes: updated.

• 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: 24068462
• Report Number: 2124215-2026-02416
• Device Sequence Number: 10227132
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: (01)08714729876748(17)260619(10)34440479
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 02/19/2026

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 Expiration Date: 06/19/2026
• Device Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0034440479
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 06/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown