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

Model Number	H74939294601210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier (b)(6).A2: age at time of event: 75 years old at the time of study enrollment.
Event or Problem Description
Elegance clinical study it was reported that in-stent thrombotic occlusion and restenosis occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left common femoral artery, left proximal superficial femoral artery (sfa), and left mid sfa with 6 mm proximal reference vessel diameter and 5.5 mm distal reference vessel diameter with lesion length 177 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with study devices, pre-dilation was performed using a 5 mm x 200 mm non-boston scientific balloon.Treatment of target lesion was performed by dilation using 5 mm x 200 mm and 6 mm x 200 mm ranger drug coated balloons and placement of 6 mm x 120 mm and 6 mm x 100 mm eluvia drug eluting stents study device.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2024, the subject visited the hospital for follow up of peripheral artery disease, and vascular ultrasound ankle brachial index (abi) without exercise performed revealed the following in the left leg: severe arterial occlusive disease at rest with monophasic flow in posterior tibial artery and dorsalis pedis artery.Multiphasic flow was noted in common femoral artery and popliteal artery.Abi was noted to be 0.33.On (b)(6) 2024, left lower extremity arterial duplex revealed thrombotic occlusion in left proximal sfa and occlusion of sfa stent from mid portion to knee.Monophasic flow noted distally in the left popliteal artery through the calf.On 05-sep-2024, subject presented to the hospital with complaint of rest pain in left leg in the setting of having to hold antiplatelet therapy prior to cholecystectomy.On the same day, left lower extremity angiography revealed severe in-stent restenosis in sfa with chronic occlusion in proximal sfa, diffuse mild atherosclerotic disease in popliteal artery and anterior tibial artery, severe atherosclerotic disease with chronic occlusion in distal segment of posterior tibial artery.No evidence of significant disease was noted in common iliac artery, external iliac artery, internal iliac artery, common femoral artery, profunda femoris artery, tibial peroneal trunk, peroneal artery and dorsalis pedis artery.On (b)(6) 2024, 727 days post index procedure, thrombotic in-stent occlusion noted in left sfa was treated by thrombectomy using non-boston scientific thrombectomy device followed by balloon angioplasty using 4 mm x 80 mm and 5 mm x 200 mm non-boston scientific balloons and two 6 mm x 200 mm non-boston scientific drug coated balloons.Subsequently, angiogram performed revealed slow flow in the left anterior tibial and left dorsalis pedis arteries concerning for distal embolization, which was treated by thrombectomy using non-boston scientific thrombectomy device followed by balloon angioplasty using 2.5 mm x 120 mm and 2 mm x 200 mm non-boston scientific balloons.Final angiogram revealed restoration of flow of the left anterior tibial and dorsalis pedis arteries and patent brisk flow in the left sfa and left popliteal arteries.
Event or Problem Description
It was reported via clinical study that in-stent thrombotic occlusion and restenosis occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2022 as a part of a clinical trial.The target lesion was in the left common femoral artery, left proximal superficial femoral artery (sfa), and left mid sfa with 6 mm proximal reference vessel diameter and 5.5 mm distal reference vessel diameter with lesion length 177 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with study devices, pre-dilation was performed using a 5 mm x 200 mm non-boston scientific balloon.Treatment of target lesion was performed by dilation using 5 mm x 200 mm and 6 mm x 200 mm ranger drug coated balloons and placement of 6 mm x 120 mm and 6 mm x 100 mm eluvia drug eluting stents study device.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2024, the subject visited the hospital for follow up of peripheral artery disease, and vascular ultrasound ankle brachial index (abi) without exercise performed revealed the following in the left leg: severe arterial occlusive disease at rest with monophasic flow in posterior tibial artery and dorsalis pedis artery.Multiphasic flow was noted in common femoral artery and popliteal artery.Abi was noted to be 0.33.On (b)(6) 2024, left lower extremity arterial duplex revealed thrombotic occlusion in left proximal sfa and occlusion of sfa stent from mid portion to knee.Monophasic flow noted distally in the left popliteal artery through the calf.On (b)(6) 2024, subject presented to the hospital with complaint of rest pain in left leg in the setting of having to hold antiplatelet therapy prior to cholecystectomy.On the same day, left lower extremity angiography revealed severe in-stent restenosis in sfa with chronic occlusion in proximal sfa, diffuse mild atherosclerotic disease in popliteal artery and anterior tibial artery, severe atherosclerotic disease with chronic occlusion in distal segment of posterior tibial artery.No evidence of significant disease was noted in common iliac artery, external iliac artery, internal iliac artery, common femoral artery, profunda femoris artery, tibial peroneal trunk, peroneal artery and dorsalis pedis artery.On (b)(6) 2024, 727 days post index procedure, thrombotic in-stent occlusion noted in left sfa was treated by thrombectomy using non-boston scientific thrombectomy device followed by balloon angioplasty using 4 mm x 80 mm and 5 mm x 200 mm non-boston scientific balloons and two 6 mm x 200 mm non-boston scientific drug coated balloons.Subsequently, angiogram performed revealed slow flow in the left anterior tibial and left dorsalis pedis arteries concerning for distal embolization, which was treated by thrombectomy using non-boston scientific thrombectomy device followed by balloon angioplasty using 2.5 mm x 120 mm and 2 mm x 200 mm non-boston scientific balloons.Final angiogram revealed restoration of flow of the left anterior tibial and dorsalis pedis arteries and patent brisk flow in the left sfa and left popliteal arteries.It was further reported that the subject was not on antiplatelet medications, and this event was related to disease progression.Per the investigator, this event was not related to the eluvia stent.
Additional Manufacturer Narrative
A2: age at time of event: 75 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: 21160480
• Report Number: 2124215-2024-83956
• Device Sequence Number: 7573351
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/11/2025

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: 01/11/2024
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0028746125
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 01/11/2022
• 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: Female
• Patient Race: White