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

Model Number	H74939294601510
Medical Device Problem Codes	Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage and stent malposition occurred requiring additional intervention.The 100% stenosed target lesion was located in the non-tortuous and severely calcified peripheral artery via contralateral approach.A 6fr contralateral sheath was placed into the right superficial femoral artery (sfa).Multiple wires were used to cross the chronic total occlusion (cto) of the sfa.A 4x220 sterling was used to pre dilate.The lesion was 50% stenosed after predilation.A 6x150,130cm eluvia was selected for use.During the procedure, the stent was advanced to the distal sfa and upon deployment, it was noted that the wheel stopped advancing.Attempts to further deploy, the stent, were made by using the grip handle and pulling the device.However, as a result, the stent elongated 380cm and was deployed in the wrong location.The device and 300cm v18 wire were removed together as the wire was stuck.Multiple stents were deployed.There were no patient complications as a result of this event.The patient was expected to fully recover.
Additional Manufacturer Narrative
H6 - evaluation conclusion codes: updated.
Event or Problem Description
It was reported that stent damage and stent malposition occurred requiring additional intervention.The 100% stenosed target lesion was located in the non-tortuous and severely calcified peripheral artery via contralateral approach.A 6fr contralateral sheath was placed into the right superficial femoral artery (sfa).Multiple wires were used to cross the chronic total occlusion (cto) of the sfa.A 4x220 sterling was used to pre dilate.The lesion was 50% stenosed after predilation.A 6x150,130cm eluvia was selected for use.During the procedure, the stent was advanced to the distal sfa and upon deployment, it was noted that the wheel stopped advancing.Attempts to further deploy, the stent, were made by using the grip handle and pulling the device.However, as a result, the stent elongated 380cm and was deployed in the wrong location.The device and 300cm v18 wire were removed together as the wire was stuck.Multiple stents were deployed.There were no patient complications as a result of this event.The patient was expected to fully recover.

• 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: 23863736
• Report Number: 2124215-2025-92262
• Device Sequence Number: 21325581
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)270313(10)36296867
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 02/04/2026

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 Model Number: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0036296867
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 03/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE SHEATH: TERUMO 6FR 45 CM; GUIDE SHEATH: TERUMO 6FR 45 CM; GUIDEWIRE: 300CM V18; GUIDEWIRE: 300CM V18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 98 KG