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

Model Number	H74939294701510
Medical Device Problem Codes	Entrapment of Device (1212); 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	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this stent started to deploy before the yellow tab was removed.A 7mm x 150mm, 130cm eluvia self-expanding stent was selected for treatment of stenosis in the superficial femoral artery.The lesion was 70 percent stenosed with moderate tortuosity and moderate calcification.While advancing the stent over the wire, the delivery system stopped tracking and got stuck on the wire.When removing the wire and delivery system, the stent was partially starting to deploy even though the yellow tab was never removed.The procedure was completed with another eluvia without sequelae.
Additional Manufacturer Narrative
Device eval by manufacturer: this eluvia was returned and analyzed.A visual and tactile examination identified an outer sheath kink 1 mm distal from the distal end of the handle.The handle of the device was opened and there was no evidence of inner prolapse.The device was received with the stent partially deployed on the delivery system and the safety lock was still in place on the handle of the device; however, was unable to be further deployed due to the outer sheath kink.The allegation from the field was confirmed through analysis.
Event or Problem Description
It was reported that this stent started to deploy before the yellow tab was removed.A 7mm x 150mm, 130cm eluvia self-expanding stent was selected for treatment of stenosis in the superficial femoral artery.The lesion was 70 percent stenosed with moderate tortuosity and moderate calcification.While advancing the stent over the wire, the delivery system stopped tracking and got stuck on the wire.When removing the wire and delivery system, the stent was partially starting to deploy even though the yellow tab was never removed.The procedure was completed with another eluvia without sequelae.

• 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: 21652156
• Report Number: 2124215-2025-17247
• Device Sequence Number: 17998174
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: (01)08714729876748(17)251025(10)32840875
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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 Expiration Date: 10/25/2025
• Device Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0032840875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• Patient Sex: Unknown