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

Model Number	H74939294601510
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partial deployment and break occurred requiring additional intervention.The approximately 20-30% stenosed target lesion was located in a non-tortuous and mildly calcified vessel via contralateral approach.A 6x150,130cm eluvia was selected for use.During the procedure, the stent was successfully advanced over a.014 wire and 80-90% of the stent was deployed inside a previously placed 6x150 eluvia stent.During the end of deployment, the physician pined and pulled the blue plunger and the last part of the stent remained inside the eluvia deployment shaft.The handle was then split in two and the physician tried to pin the gold wire of the device and pull the silver part, and it would still not deploy.The physician then pulled the stent back into the sheath, which ended up stretching approximately 50-100mm of the eluvia stent.The stent broke and most of the stent was inside the sheath.The remaining 120mm of the stent was deployed inside the patient.A rubicon was placed, and the wire was able to be exchanged for a.035 wire.The sheath was then removed, and a new sheath was placed.A 6x200 charger balloon was used to predilate the entire superficial femoral artery (sfa).Another 6x150 eluvia was placed and deployed appropriately.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: 23582819
• Report Number: 2124215-2025-81909
• Device Sequence Number: 18552058
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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
• Report Date (Section B): 11/18/2025

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 Model Number: H74939294601510
• Device Catalogue Number: H74939294601510
• 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: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• 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