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); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was damaged and failed to expand, requiring placement of additional stent.The 80-85% stenosed target lesion was located in the non-tortuous and mildly calcified peripheral artery.A 7x150, 130 cm eluvia stent was selected for treatment.The device was prepared and attempted to be deployed as normal via contralateral approach.However, during deployment, it was observed that the distal one-third of the stent appeared twisted, resulting in only 75-80% (120 mm) of the stent expanding fully.The procedure was completed after placement of a second eluvia stent to open the twisted area, followed by lining both stents with a long non-boston scientific stent graft.There were no complications as a result of this event, and the patient fully recovered following the procedure.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the eluvia stent was returned to our post market quality assurance laboratory.The device was received with the stent fully deployed from the delivery system.The stent was not returned for analysis.A visual and tactile examination found no issues with the tip of the device.A visual and tactile examination found the sheath of the device to be kinked at more than one location.A visual examination found the rack section of handle to be broken.The proximal section of the separated rack was not returned for analysis.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the eluvia device confirmed that the event of stent material deformation and stent failure to expand are known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported that the stent was damaged and failed to expand, requiring placement of additional stent.The 80-85% stenosed target lesion was located in the non-tortuous and mildly calcified peripheral artery.A 7x150, 130 cm eluvia stent was selected for treatment.The device was prepared and attempted to be deployed as normal via contralateral approach.However, during deployment, it was observed that the distal one-third of the stent appeared twisted, resulting in only 75-80% (120 mm) of the stent expanding fully.The procedure was completed after placement of a second eluvia stent to open the twisted area, followed by lining both stents with a long non-boston scientific stent graft.There were no complications as a result of this event, and the patient fully recovered following the procedure.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24367752
• Report Number: 2124215-2026-08874
• Device Sequence Number: 13181472
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: (01)08714729876748(17)270110(10)35694495
• 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
• Device Implanted Year: 2026
• 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): 04/09/2026

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 Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0035694495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT GRAFT - VIABAHN; STENT GRAFT - VIABAHN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown