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

Model Number	H74939294701210
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and became stretched.This 7x120, 130 cm eluvia stent was selected for use during an angiogram to treat atherosclerosis of the superficial femoral artery.During the procedure, using a pedal approach, the stent was 60% deployed when the thumb wheel would no longer move, and pull grip felt loose.Therefore, the physician broke the pull handle to try and deploy the stent.Initially, the wire would not deploy the stent; however, after approximately 30 minutes, the stent was able to be fully deployed with the wire.The stent became elongated to approximately 200cm as a result of this.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluate by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia device was received with the components separated.A visual examination identified that the handle was in two separate pieces; the thumb wheel was detached from the handle and the rack was detached from the handle.A visual and tactile examination found an inner sheath kink approximately 60mm proximal from the distal end of the rack.The device was received with the stent already deployed from the delivery system.A visual examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that the stent partially deployed and became stretched.This 7 x 120, 130 cm eluvia stent was selected for use during an angiogram to treat atherosclerosis of the superficial femoral artery.During the procedure, using a pedal approach, the stent was 60% deployed when the thumb wheel would no longer move, and pull grip felt loose.Therefore, the physician broke the pull handle to try and deploy the stent.Initially, the wire would not deploy the stent; however, after approximately 30 minutes, the stent was able to be fully deployed with the wire.The stent became elongated to approximately 200 cm as a result of this.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21744723
• Report Number: 2124215-2025-18316
• Device Sequence Number: 3993482
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: (01)08714729876731(17)260621(10)34404212
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/14/2025

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: 06/21/2026
• Device Model Number: H74939294701210
• Device Catalogue Number: H74939294701210
• Device Lot Number: 0034404212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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