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

Model Number	H74939294701510
Medical Device Problem Codes	Fracture (1260); Activation Failure (3270)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fractured occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 7x150, 130 cm eluvia stent had been previously implanted on (b)(6) 2025.The patient returned to the healthcare facility on (b)(6) 2025.Extensive vessel prep was performed including 3 hours of angiosculpt and shockwave ivl.At this time it was observed that the implanted eluvia stent had multiple fractures with separation along the length of the stent.The stent appeared elongated by approximately 5 cm from the distal portion and was not fully expanded.The damaged portion of the stent remained fully deployed in the vessel and was not removed, with additional intervention to be discussed.The patient was placed on ekos therapy and will be re-evaluated.
Event or Problem Description
It was reported that stent fractured occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 7x150, 130 cm eluvia stent had been previously implanted on (b)(6) 2025.The patient returned to the healthcare facility on 27oct2025.Extensive vessel prep was performed including 3 hours of angiosculpt and shockwave ivl.At this time it was observed that the implanted eluvia stent had multiple fractures with separation along the length of the stent.The stent appeared elongated by approximately 5 cm from the distal portion and was not fully expanded.The damaged portion of the stent remained fully deployed in the vessel and was not removed, with additional intervention to be discussed.The patient was placed on ekos therapy and will be re-evaluated.
Additional Manufacturer Narrative
H6 - device codes: corrected.
Event or Problem Description
It was reported that stent fractured occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 7x150, 130 cm eluvia stent had been previously implanted on (b)(6) 2025.The patient returned to the healthcare facility on (b)(6) 2025.Extensive vessel prep was performed including 3 hours of angiosculpt and shockwave ivl.At this time it was observed that the implanted eluvia stent had multiple fractures with separation along the length of the stent.The stent appeared elongated by approximately 5 cm from the distal portion and was not fully expanded.The damaged portion of the stent remained fully deployed in the vessel and was not removed, with additional intervention to be discussed.The patient was placed on ekos therapy and will be re-evaluated.It was further reported that the initial procedure was performed on (b)(6) 2024, involving the segment from the superficial femoral artery to the popliteal artery.Vessel preparation and stent implantation were performed during the initial intervention in 2024.It could not be determined when the stent fracture or thrombus formation occurred, as these findings were discovered intraprocedurally on (b)(6) 2025.The stent fracture was possibly secondary to severe vessel calcification.
Additional Manufacturer Narrative
B3 - date of event: updated.B5- describe event or problem: updated with additional information.H6 - device codes: corrected.

• 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: 23621717
• Report Number: 2124215-2025-85517
• Device Sequence Number: 9997721
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: (01)08714729876748(17)241201(10)30842407
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 01/08/2026

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 Expiration Date: 12/01/2024
• Device Model Number: H74939294701510
• Device Catalogue Number: H74939294701510
• Device Lot Number: 0030842407
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 12/15/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/08/2026
• Date Device Manufactured: 12/02/2022
• 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: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 79 KG