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

Model Number	H74939294701510
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partial deployment and fracture occurred.Vascular access was gained via contralateral approach.The 100% stenosed target lesion was located in the moderately tortuous and moderate to severely calcified artery in the right leg.Severe tortuosity was noted in the iliac artery.A 7x150, 130 cm eluvia was selected for use.The stent was prepped as normal and delivered to the treatment zone over a.014 non-boston scientific guidewire.The stent was predilated with a 6x150 sterling balloon.During deployment, the stent was partially deployed 80mm and resistance was felt with the thumb wheel.The deployment shaft was used to deploy the stent; however, the shaft slid back.The deployment handle was opened and an attempt to manually deploy the stent by pulling the inner hypotube was performed.The mid-section of the stent stretched and fractured in the process of deployment.Kinks were noted within the deployment mechanism.The guidewire and the remaining device were removed from the patient.The retained portion of the stent was post dilated, and the decision was made to leave angiographic results alone.There were no patient complications and the patient fully recovered.
Event or Problem Description
It was reported that stent partial deployment and fracture occurred.Vascular access was gained via contralateral approach.The 100% stenosed target lesion was located in the moderately tortuous and moderate to severely calcified artery in the right leg.Severe tortuosity was noted in the iliac artery.A 7x150, 130 cm eluvia was selected for use.The stent was prepped as normal and delivered to the treatment zone over a.014 non-boston scientific guidewire.The stent was predilated with a 6x150 sterling balloon.During deployment, the stent was partially deployed 80mm and resistance was felt with the thumb wheel.The deployment shaft was used to deploy the stent; however, the shaft slid back.The deployment handle was opened and an attempt to manually deploy the stent by pulling the inner hypotube was performed.The mid-section of the stent stretched and fractured in the process of deployment.Kinks were noted within the deployment mechanism.The guidewire and the remaining device were removed from the patient.The retained portion of the stent was post dilated, and the decision was made to leave angiographic results alone.There were no patient complications and the patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system with a 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open and missing.There are multiple kinks along the sheath.The proximal inner liner is prolapsed.The stent measured approximately 10.6cm to the separation and approximately 5mm of the stent is protruding out from the middle sheath.The distal end of the separated stent did not return for analysis.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 21164043
• Report Number: 2124215-2025-01253
• Device Sequence Number: 13146417
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/18/2025

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 Expiration Date: 02/15/2026
• Device Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0033619972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: .014 SPARTACORE; GUIDEWIRE: .014 SPARTACORE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Race: White