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

Model Number	H74939294601510
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed, and the stent fractured during removal, resulting in a cancelled procedure.A 6x150, 130 cm eluvia drug-eluting self-expanding stent was selected for use in a total occlusion of the superficial femoral artery.During the procedure, it was noted that the stent partially deployed and would not fully deploy.Since the deployed part of the stent could not be recaptured, the physician attempted to remove the stent, but the stent began to fracture.The stent, the deployment system, and the access sheath were removed together.Manual pressure was applied to the access site.The access site was compromised, so the procedure was aborted.There were no patient complications as a result of this event, and the patient fully recovered.
Event or Problem Description
It was reported that the stent partially deployed, and the stent fractured during removal, resulting in a cancelled procedure.A 6x150, 130 cm eluvia drug-eluting self-expanding stent was selected for use in a total occlusion of the superficial femoral artery.During the procedure, it was noted that the stent partially deployed and would not fully deploy.Since the deployed part of the stent could not be recaptured, the physician attempted to remove the stent, but the stent began to fracture.The stent, the deployment system, and the access sheath were removed together.Manual pressure was applied to the access site.The access site was compromised, so the procedure was aborted.There were no patient complications as a result of this event, and the patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: the eluvia was returned for analysis.A visual and tactile examination identified multiple outer sheath kinks.The device was received with part of the stent already deployed from the delivery system.The stent was noted to be severely damaged and part of the stent was detached and the other part was still attached to device.Organic matter was attached to part of the stent.A visual examination identified no issues with the tip of the device.A visual examination identified no issues or damage to the handle of the device.The investigator opened the handle of the device.There was no evidence of inner prolapse.

• 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: 23745757
• Report Number: 2124215-2025-87500
• Device Sequence Number: 12865117
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)270523(10)36828845
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 02/06/2026

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: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0036828845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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