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

Model Number	H74939294701510
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an additional stent was used during the procedure.The 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery and lower extremity.After pre-dilation, the lesion was reduced to 40-70% stenosis and was noted to be mildly tortuous with mild to moderate calcification.A 7x150, 130 cm eluvia drug-eluting stent was selected for treatment via contralateral approach.During deployment, the thumbwheel was used until the white arrow was visible, and the force required to turn the thumbwheel was normal.The white arrow was observed prior to using the pull grip.However, when approximately 30 mm of the stent had been deployed, it was noted that the middle shaft did not retract to proximal stent markers.Additional manipulation of the delivery system was required to fully deploy the stent, including rotation of the handle, thumbwheel and pull grip.The stent was eventually implanted, but it became stretched and elongated at approximately 15 to150cm.The delivery system was removed over the wire, and the procedure was completed by placing additional stent to line the elongated portion.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that an additional stent was used during the procedure.The 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery and lower extremity.After pre-dilation, the lesion was reduced to 40-70% stenosis and was noted to be mildly tortuous with mild to moderate calcification.A 7x150, 130 cm eluvia drug-eluting stent was selected for treatment via contralateral approach.During deployment, the thumbwheel was used until the white arrow was visible, and the force required to turn the thumbwheel was normal.The white arrow was observed prior to using the pull grip.However, when approximately 30 mm of the stent had been deployed, it was noted that the middle shaft did not retract to proximal stent markers.Additional manipulation of the delivery system was required to fully deploy the stent, including rotation of the handle, thumbwheel and pull grip.The stent was eventually implanted, but it became stretched and elongated at approximately 15 to150cm.The delivery system was removed over the wire, and the procedure was completed by placing additional stent to line the elongated portion.There were no patient complications as a result of this event.It was further reported that the correct length of stent elongation was approximately 10-15 cm, and two additional stents were placed as a result of this event: 7x120 eluvia drug-eluting stents.

• 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: 23437072
• Report Number: 2124215-2025-76824
• Device Sequence Number: 4732954
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: (01)08714729876748(17)260215(10)33619972
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/21/2025

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: 02/15/2026
• Device Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0033619972
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 02/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White