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

Model Number	H74939294600410
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort has been sent to confirm the patient outcome and if the stent was removed; however, has not been obtained at the time this report was sent.
Event or Problem Description
It was reported that stent migration occurred.A 6x40, 130 cm eluvia self-expanding stent was selected for a fistulagram.Physician used thrombectomy and angioplasty in the subclavian artery.The subclavian artery had a tight lesion, even after angioplasty, and the physician then requested the 6x40, 130 cm eluvia self-expanding stent.When deploying the eluvia, good placement was not achieved, and the stent was undersized.The stent then started to migrate.Attempts to retrieve the stent were unsuccessful, so the patient was transferred to another facility for intervention.
Additional Manufacturer Narrative
Correction: a2- date of birth corrected.B5: additional information added.
Event or Problem Description
It was reported that stent migration occurred.A 6x40, 130 cm eluvia self-expanding stent was selected for a fistulagram.Physician used thrombectomy and angioplasty in the subclavian artery.The subclavian artery had a tight lesion, even after angioplasty, and the physician then requested the 6x40, 130 cm eluvia self-expanding stent.When deploying the eluvia, good placement was not achieved, and the stent was undersized.The stent then started to migrate.Attempts to retrieve the stent were unsuccessful, so the patient was transferred to another facility for intervention.It was further reported that the stent was successfully removed.The patient is doing fine.
Additional Manufacturer Narrative
Correction: b1- adverse event/product problem added.B5: additional information added.D4: udi # updated.H6: impact code added.
Event or Problem Description
It was reported that stent migration occurred.A 6x40, 130 cm eluvia self-expanding stent was selected for a fistulagram.Physician used thrombectomy and angioplasty in the subclavian artery.The subclavian artery had a tight lesion, even after angioplasty, and the physician then requested the 6x40, 130 cm eluvia self-expanding stent.When deploying the eluvia, good placement was not achieved, and the stent was undersized.The stent then started to migrate.Attempts to retrieve the stent were unsuccessful, so the patient was transferred to another facility for intervention.It was further reported that the stent was successfully removed.The patient is doing fine.It was again further reported that the 100% stenosed lesion was located in a very tortuous subclavian artery.At the other hospital, the stent was surgically removed.
Additional Manufacturer Narrative
Correction: h6- updated code from foreign body in patient to no clinical signs, symptoms, or conditions.
Event or Problem Description
It was reported that stent migration occurred.A 6x40, 130 cm eluvia self-expanding stent was selected for a fistulagram.Physician used thrombectomy and angioplasty in the subclavian artery.The subclavian artery had a tight lesion, even after angioplasty, and the physician then requested the 6x40, 130 cm eluvia self-expanding stent.When deploying the eluvia, good placement was not achieved, and the stent was undersized.The stent then started to migrate.Attempts to retrieve the stent were unsuccessful, so the patient was transferred to another facility for intervention.It was further reported that the stent was successfully removed.The patient is doing fine.It was again further reported that the 100% stenosed lesion was located in a very tortuous subclavian artery.At the other hospital, the stent was surgically removed.
Event or Problem Description
It was reported that stent migration occurred.A 6x40, 130 cm eluvia self-expanding stent was selected for a fistulagram.Physician used thrombectomy and angioplasty in the subclavian artery.The subclavian artery had a tight lesion, even after angioplasty, and the physician then requested the 6x40, 130 cm eluvia self-expanding stent.When deploying the eluvia, good placement was not achieved, and the stent was undersized.The stent then started to migrate.Attempts to retrieve the stent were unsuccessful, so the patient was transferred to another facility for intervention.It was further reported that the stent was successfully removed.The patient is doing fine.It was again further reported that the 100% stenosed lesion was located in a very tortuous subclavian artery.At the other hospital, the stent was surgically removed.
Additional Manufacturer Narrative
Correction: h6.Patient codes.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with (b)(4), which focused on identifying and remediating incomplete coding of events.Device analysis results: analysis could not be performed, as the device was not returned.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are 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 risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a conclusion code of unintended use error caused or contributed to event.This was based on the reported under sizing of the stent which contributed to the migration issue.

• 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: 21657965
• Report Number: 2124215-2025-14915
• Device Sequence Number: 8346770
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: (01)08714729876571(17)251018(10)32822222
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup,Followup,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 Expiration Date: 10/18/2025
• Device Model Number: H74939294600410
• Device Catalogue Number: H74939294600410
• Device Lot Number: 0032822222
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 04/02/2025; 04/24/2025; 03/30/2026
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 03/24/2025; 04/02/2025; 05/20/2025; 04/24/2026
• Date Device Manufactured: 10/19/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male