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); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: age at time of event: 76 years old at the time of study enrollment.
Event or Problem Description
Elegance clinical study: it was reported that in-stent restenosis occurred.The subject underwent treatment with ranger drug-coated balloons and an eluvia drug-eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left distal superficial femoral artery (sfa), left proximal extending up to distal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 190 mm and 100% stenosis.It was classified as a tasc ii c lesion.Prior to target lesion treatment with the study device, 4.0 mm non-boston scientific embolization protection device was used and pre dilation was performed by using 5 mm x 150 mm and 4 mm x 40 mm non-boston scientific balloons.Treatment of target lesion was performed by dilation using study devices of sizes 4 mm x 40 mm, 5 mm x 200 mm, and 5 mm x 60 mm ranger drug-coated balloons followed by placement of study device 6 mm x 60 mm eluvia drug-eluting stent.Post dilation was performed using 5 mm x 20 mm nc emerge ptca dilation catheter, and the final residual stenosis was noted to be 30%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, ankle-brachial index (abi) was assessed in view of severe bilateral peripheral arterial disease which revealed right abi: 174 and left abi: 182.On (b)(6) 2023, the subject presented to her cardiologist due to claudication in the left lower extremity with some pain at rest, and coldness in left foot.The subject was referred for peripheral angiogram with possible intervention and hospitalized for the same.On the same day, peripheral angiogram in left leg revealed: patent common iliac, external iliac, internal iliac, profunda, and peroneal arteries, mild focal stenosis was noted in common femoral artery, severe in-stent restenosis of proximal to mid portion of stents with total occlusion of the distal stent in sfa (target lesion) with reconstitution in the tibial peroneal trunk (tpt) stent, occlusion was noted in the left popliteal artery (target lesion) stent, occlusion was noted in the anterior tibial artery, proximal portion of posterior tibial artery and tpt stent with distal flow via collaterals.On (b)(6) 2023, 541 days post index procedure, thrombotic occlusion noted in left distal sfa, popliteal artery, and tpt was treated by direct pharmaceutical thrombolysis using 20 mg tpa via microcatheter followed by dilation using 4.0 mm x 150 mm non-boston scientific balloon.Then two 5 mm x 150 non-boston scientific balloons to treat popliteal to tpt and distal sfa to popliteal artery respectively.Subsequently, thrombectomy was performed from sfa to tpt using non-boston scientific thrombectomy device.Then dilation was performed using 4.0 mm x 60 mm non-boston scientific drug-coated balloon in popliteal, tpt and peroneal artery.Following this, a 6.0 mm x 120 mm eluvia drug-eluting stent was placed in the distal sfa to proximal popliteal artery and was post-dilated using a 6.0 mm x 100 mm sterling balloon.There was an excellent angiographic result following this intervention.Additionally, in-stent restenosis noted in left proximal and mid sfa was treated using 5.0 mm x 120 mm non-boston scientific drug-coated balloon and stenosis noted in tibial peroneal trunk and peroneal artery was treated by dilation using 3 mm x 60 mm non-boston scientific balloon.Following treatment, the angiogram revealed excellent results and the final residual stenosis was noted to be 20%.On the same day, the event was considered resolved and the subject was discharged from the hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2: age at time of event: 76 years old at the time of study enrollment.
Event or Problem Description
It was reported that in-stent restenosis occurred.The subject underwent treatment with ranger drug-coated balloons and an eluvia drug-eluting stent on (b)(6) 2022 as a part of a clinical trial.The target lesion was in the left distal superficial femoral artery (sfa), left proximal extending up to distal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 190 mm and 100% stenosis.It was classified as a tasc ii c lesion.Prior to target lesion treatment with the study device, 4.0 mm non-boston scientific embolization protection device was used and pre dilation was performed by using 5 mm x 150 mm and 4 mm x 40 mm non-boston scientific balloons.Treatment of target lesion was performed by dilation using study devices of sizes 4 mm x 40 mm, 5 mm x 200 mm, and 5 mm x 60 mm ranger drug-coated balloons followed by placement of study device 6 mm x 60 mm eluvia drug-eluting stent.Post dilation was performed using 5 mm x 20 mm nc emerge ptca dilation catheter, and the final residual stenosis was noted to be 30%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, ankle-brachial index (abi) was assessed in view of severe bilateral peripheral arterial disease which revealed right abi: 174 and left abi: 182.On (b)(6) 2023, the subject presented to her cardiologist due to claudication in the left lower extremity with some pain at rest, and coldness in left foot.The subject was referred for peripheral angiogram with possible intervention and hospitalized for the same.On the same day, peripheral angiogram in left leg revealed: patent common iliac, external iliac, internal iliac, profunda, and peroneal arteries, mild focal stenosis was noted in common femoral artery, severe in-stent restenosis of proximal to mid portion of stents with total occlusion of the distal stent in sfa (target lesion) with reconstitution in the tibial peroneal trunk (tpt) stent, occlusion was noted in the left popliteal artery (target lesion) stent, occlusion was noted in the anterior tibial artery, proximal portion of posterior tibial artery and tpt stent with distal flow via collaterals.On (b)(6) 2023, 541 days post index procedure, thrombotic occlusion noted in left distal sfa, popliteal artery, and tpt was treated by direct pharmaceutical thrombolysis using 20 mg tpa via microcatheter followed by dilation using 4.0 mm x 150 mm non-boston scientific balloon.Then two 5 mm x 150 non-boston scientific balloons to treat popliteal to tpt and distal sfa to popliteal artery respectively.Subsequently, thrombectomy was performed from sfa to tpt using non-boston scientific thrombectomy device.Then dilation was performed using 4.0 mm x 60 mm non-boston scientific drug-coated balloon in popliteal, tpt and peroneal artery.Following this, a 6.0 mm x 120 mm eluvia drug-eluting stent was placed in the distal sfa to proximal popliteal artery and was post-dilated using a 6.0 mm x 100 mm sterling balloon.There was an excellent angiographic result following this intervention.Additionally, in-stent restenosis noted in left proximal and mid sfa was treated using 5.0 mm x 120 mm non-boston scientific drug-coated balloon and stenosis noted in tibial peroneal trunk and peroneal artery was treated by dilation using 3 mm x 60 mm non-boston scientific balloon.Following treatment, the angiogram revealed excellent results and the final residual stenosis was noted to be 20%.On the same day, the event was considered resolved and the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that the eluvia device was not related to the event of left femoropopliteal artery restenosis.

• 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: 18946299
• Report Number: 2124215-2024-16693
• Device Sequence Number: 8030964
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 06/11/2025

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: 07/03/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027799329
• 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: 05/15/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: White