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

Model Number	24657
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: age at time of event: 57 years old at the time of study enrollment.
Event or Problem Description
Elegance clinical trial.It was reported that in-stent occlusion occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa) with a 6.5 mm proximal reference vessel diameter and a 6.5 mm distal reference vessel diameter with lesion length 50 mm with 95% stenosis and was classified as a tasc ii a lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed with a 5.0 mm x 40 mm sterling pta balloon.Treatment of target lesion was performed by placement of study device: 7 mm x 60 mm eluvia drug-eluting stent.Post-dilation was performed with a 7.0 mm x 40 mm mustang otw pta balloon, and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, during study specific 12-month follow up visit, right lower extremity arterial duplex was performed which revealed occluded stent from right proximal sfa to right mid sfa with re-constitution in the right distal sfa and 20-49% stenosis in right profunda femoris artery.Based on these findings, no action was taken at that time.On (b)(6) 2023, the subject visited hospital with complaints of right leg pain and discomfort in the right lower extremity, mostly in calf.Physical examination revealed femoral pulses intact bilaterally, non-palpable pedal pulses bilaterally, palpable left pt pulses bilaterally, faint dopplerable right distal anterior tibial dorsalis pedal pulse and no signs of cyanosis and coolness noted.Based on these findings, right femoral-popliteal artery bypass surgery was planned.On (b)(6) 2023, subject visited the hospital for planned bypass surgery and was hospitalized on the same day for further treatment.On (b)(6) 2023, 525 days post index procedure, occlusion noted in the right proximal sfa was treated with endarterectomy and right femoral artery to popliteal artery bypass surgery using a 6 mm non-boston scientific vascular graft.Post procedure, the final residual stenosis was noted to be 0%.Subsequently, plaque noted in the right common artery and right profunda femoris artery was treated with endarterectomy.Post procedure, the subject had palpable dorsalis pedis and posterior tibial pulse.On (b)(6) 2023, the event was considered resolved and on the same day, subject was discharged on clopidogrel.
Additional Manufacturer Narrative
A2: age at time of event: 57 years old at the time of study enrollment.
Event or Problem Description
It was reported that in-stent occlusion occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2021 as a part of a clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa) with a 6.5 mm proximal reference vessel diameter and a 6.5 mm distal reference vessel diameter with lesion length 50 mm with 95% stenosis and was classified as a tasc ii a lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed with a 5.0 mm x 40 mm sterling pta balloon.Treatment of target lesion was performed by placement of study device: 7 mm x 60 mm eluvia drug-eluting stent.Post-dilation was performed with a 7.0 mm x 40 mm mustang otw pta balloon, and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, during study specific 12-month follow up visit, right lower extremity arterial duplex was performed which revealed occluded stent from right proximal sfa to right mid sfa with re-constitution in the right distal sfa and 20-49% stenosis in right profunda femoris artery.Based on these findings, no action was taken at that time.On (b)(6) 2023, the subject visited hospital with complaints of right leg pain and discomfort in the right lower extremity, mostly in calf.Physical examination revealed femoral pulses intact bilaterally, non-palpable pedal pulses bilaterally, palpable left pt pulses bilaterally, faint dopplerable right distal anterior tibial dorsalis pedal pulse and no signs of cyanosis and coolness noted.Based on these findings, right femoral-popliteal artery bypass surgery was planned.On (b)(6) 2023, subject visited the hospital for planned bypass surgery and was hospitalized on the same day for further treatment.On (b)(6) 2023, 525 days post index procedure, occlusion noted in the right proximal sfa was treated with endarterectomy and right femoral artery to popliteal artery bypass surgery using a 6 mm non-boston scientific vascular graft.Post procedure, the final residual stenosis was noted to be 0%.Subsequently, plaque noted in the right common artery and right profunda femoris artery was treated with endarterectomy.Post procedure, the subject had palpable dorsalis pedis and posterior tibial pulse.On (b)(6) 2023, the event was considered resolved and on the same day, subject was discharged on clopidogrel.It was further reported that the per the investigator, this event was not related to the eluvia stent.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• 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: 17686760
• Report Number: 2124215-2023-47381
• Device Sequence Number: 20441782
• Product Code: NIU
• UDI-Device Identifier: 08714729876700
• UDI-Public: 08714729876700
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2021
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0024439740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: White