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

Model Number	H74939294600810
Medical Device Problem Codes	Nonstandard Device (1420); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was difficult to position.A 6x80, 130 cm eluvia self-expanding stent was selected for treatment.During the procedure, the physician performed a common femoral endarterectomy along with an ipsilateral external iliac stent placement.However, upon deployment, it was noted that the stent extended into the area of the endarterectomy.It felt like it was deployed longer than 80cm.The same area was then stented with a shorter eluvia after removing the stent from the open endarterectomy, and the procedure was completed.The stent shaft had not been advanced very far into the patient, and the physician may have been holding the silver sliding portion of the delivery catheter, which could potentially lead to a deployment error.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Correction to field b2: outcomes attrib to adv event.Correction to field h1: type of reportable event.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 there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the eluvia device confirmed that the reported event is a known event defined in the product's 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 difficult to position.A 6x80, 130 cm eluvia self-expanding stent was selected for treatment.During the procedure, the physician performed a common femoral endarterectomy along with an ipsilateral external iliac stent placement.However, upon deployment, it was noted that the stent extended into the area of the endarterectomy.It felt like it was deployed longer than 80cm.The same area was then stented with a shorter eluvia after removing the stent from the open endarterectomy, and the procedure was completed.The stent shaft had not been advanced very far into the patient, and the physician may have been holding the silver sliding portion of the delivery catheter, which could potentially lead to a deployment error.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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24700137
• Report Number: 2124215-2026-16599
• Device Sequence Number: 21442479
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: (01)08714729876595(17)270723(10)37251820
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 04/24/2026

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: H74939294600810
• Device Catalogue Number: H74939294600810
• Device Lot Number: 0037251820
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 07/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown