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

Model Number	H74939294601510
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent elongated, and an additional device was required.An eluvia? was selected for use in a percutaneous transluminal angioplasty procedure to treat a case of chronic total occlusion (cto).The target lesion was located in the superficial femoral artery (sfa) and was 100% stenosed.The wire crossed easily.A thrombectomy was performed using a non-boston scientific (bsc) mechanical thrombectomy device, with a non-bsc embolic protection device placed distally within the popliteal artery.An unknown 5mm balloon was used to pre-dilate the lesion, prior to the delivery of the eluvia stent.Approximately 30% of the stent was deployed when it stopped deploying.The delivery catheter was pulled, which caused the stent to elongate.The physician requested some pacemaker instruments and cracked the delivery handle open to fully deploy the stent.The physician and staff reported that the non-bsc embolic protection device was tangled up within the eluvia delivery handle.As a result, the non-bsc embolic protection device and eluvia delivery system were removed together.A second eluvia stent was placed proximally to the initial stent in order to fully treat the lesion.There were no patient complications.

• 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: 22437237
• Report Number: 2124215-2025-45083
• Device Sequence Number: 3163544
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)270116(10)35755581
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 07/08/2025

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
• Device Lot Number: 0035755581
• 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: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 01/16/2025
• 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 Age: 74 YR
• Patient Sex: Male