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

Model Number	H74939294700610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arteriosclerosis/ Atherosclerosis (4437); Unspecified Tissue Injury (4559); Restenosis (4576)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that in-stent restenosis occurred.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right distal superficial femoral artery (sfa) extending up to right proximal popliteal artery with 7 mm proximal reference vessel diameter and 7 mm distal reference vessel diameter with lesion length of 40 mm and 90% stenosis and was classified as tasc ii a lesion.Prior to the treatment of target lesion with study device, balloon dilation was performed using a 6.5 mm x 40 mm non-boston scientific balloon.Treatment of target lesion was performed by placement of a 7 mm x 60 mm eluvia drug eluting stent study device.Following treatment, post-dilation was performed using a 7 mm x 20 mm non-boston scientific balloon.Post procedure, the final residual stenosis was noted to be 15%.On the same day, the subject was discharged from hospital on clopidogrel.On (b)(6) 2024, the subject visited the hospital for follow up and was noted to have developed a wound on the posterior calf of the right leg with claudication.On the same day, the arterial examination of lower extremity revealed increased velocity of 164 cm/s at proximal portion of right sfa stent suggestive of 75-99% in-stent stenosis of right lower extremity.Ankle brachial index (abi) and toe brachial index of right leg was noted to be 0.75 and 0.41 respectively.Based on these findings, the subject was recommended for right leg angiogram with sfa and popliteal artery intervention on a later date.On (b)(6) 2024, the subject visited the hospital for planned right lower extremity angiogram which revealed 70-75% in-stent stenosis in the right distal sfa with remaining portion of sfa being patent, patent popliteal artery with three vessel run-off, occlusion of lateral segment of planter arch and patent dorsalis pedis artery.On (b)(6) 2024, 524 days post index procedure, 70-75% in-stent stenosis noted in the right distal sfa was treated by balloon dilation using a 7 mm x 60 mm non-boston scientific balloon followed by placement of an 8 mm x 7.5 mm non-boston scientific stent.Post treatment, angiogram revealed marked improvement in right sfa with good antegrade flow and no residual stenosis.On the same day, the subject was discharged from the hospital on clopidogrel.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: age at time of event: 50 years old at the time of study enrollment.

• 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: 21164038
• Report Number: 2124215-2024-83929
• Device Sequence Number: 13146285
• Product Code: NIU
• UDI-Device Identifier: 08714729876700
• UDI-Public: 08714729876700
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 01/15/2025

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: 01/06/2024
• Device Model Number: H74939294700610
• Device Catalogue Number: H74939294700610
• Device Lot Number: 0028687882
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 01/06/2022
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: White