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Model Number 1177-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vascular Dissection (3160); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
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Event Date 01/25/2024 |
Event Type
Injury
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Manufacturer Narrative
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E1 - initial reporter phone: (b)(6).
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Event Description
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Elegance clinical study it was reported that restenosis and claudication occurred.On (b)(6) 2023, subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stent as a part of the elegance clinical trial.The target lesion #001 was in the right mid popliteal artery with 4.8 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 20 mm and 60% stenosis and was classified as transatlantic inter-society consensus (tasc) ii a lesion.Treatment of target lesion was performed by dilation using 5.0 mm x 40 mm, 80 cm ranger drug-coated balloon study device.Following treatment, post-dilation was performed using 5 mm x 40 mm sterling percutaneous transluminal angioplasty (pta) balloon.Post procedure, the final residual stenosis was noted to be 10%.The target lesion #002 was in the right distal superficial femoral artery extending up to right proximal popliteal artery with 5.4 mm proximal reference vessel diameter and 5.4 mm distal reference vessel diameter with lesion length of 50 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 4 mm x 40 mm sterling pat balloon.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug-coated balloon and placement of 6 mm x 60 mm eluvia drug eluting stent study devices.Following treatment, post-dilation was performed using 5 mm x 40 mm sterling pta balloon.Post procedure, the final residual stenosis was noted to be 10%.The subject was discharged from hospital on the same day on dual antiplatelet therapy.On (b)(6) 2024, the subject presented with recurrent right lower limb claudication for several months along with calf pain after walking short distances.On (b)(6) 2024, the subject was admitted to the hospital due to right leg claudication for further evaluation and treatment.On the same day, patient underwent an angiography on right lower extremity.This revealed a 95% severe focal stenosis on the right adductor duct, 50-60% stenosis in the proximal superficial femoral artery (sfa), 20mm from origin of sfa, severe stenosis noted few centimeters below the prior lesion, and approximately 70-80 mm lower, short stenosis of 75% was noted.In addition, moderate non-significant stenosis was noted in the right mid popliteal artery, right peroneal artery and anterior tibial artery, and occlusion was noted on proximal half of right posterior tibial artery.On the same day, 295 days post index procedure, 95% stenosis was noted in the adductor duct lesion that was predilated and placed a 6 mm x 40 mm eluvia drug eluting stent.Following, post-dilation was performed using 5 mm balloon.Post treatment, the final residual stenosis was noted to be 0% and good flow was noted.In addition, 50-60 % stenosis noted in right proximal sfa was treated by pre-dilation and drug coated balloon angioplasty using a 5 mm x 200 mm ranger drug coated balloon.Post different dilations, persistent significant stenosis was noted in the right mid sfa which was treated by placement of 6 mm x 40 mm eluvia drug eluting stent.On (b)(6) 2024, the event was considered resolved.On the same day, the subject was discharged from the hospital.
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Manufacturer Narrative
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Corrections made to b2 outcome attributed to adverse event, b5 describe event or problem, h6 patient codes (removed vascular dissection), and h6 impact codes (changed from additional device required to serious injury/ illness/ impairment).E1 - initial reporter phone: (b)(6).
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Event Description
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Elegance clinical study: it was reported that restenosis and claudication occurred.On (b)(6) 2023, subject underwent treatment with ranger drug coated balloons as part of the elegance clinical trial.The target lesion #001 was in the right mid popliteal artery with 4.8 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 20 mm and 60% stenosis and was classified as transatlantic inter-society consensus (tasc) ii a lesion.Treatment of target lesion was performed by dilation using 5.0 mm x 40 mm, 80 cm ranger drug-coated balloon study device.Following treatment, post-dilation was performed using 5 mm x 40 mm sterling percutaneous transluminal angioplasty (pta) balloon.Post procedure, the final residual stenosis was noted to be 10%.The target lesion #002 was in the right distal superficial femoral artery (sfa) extending up to right proximal popliteal artery with 5.4 mm proximal reference vessel diameter and 5.4 mm distal reference vessel diameter with lesion length of 50 mm and 90% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 6 mm x 60 mm ranger drug-coated balloon study device.Following treatment, post-dilation was performed using 5 mm x 40 mm sterling pta balloon.Post procedure, the final residual stenosis was noted to be 10%.The subject was discharged from hospital on the same day on dual antiplatelet therapy.On (b)(6) 2024, the subject presented with recurrent right lower limb claudication for several months along with calf pain after walking short distances.On (b)(6) 2024, the subject was admitted to the hospital due to right leg claudication for further evaluation and treatment.On the same day, patient underwent an angiography on right lower extremity.This revealed a 95% severe focal stenosis on the right adductor duct, 50-60% stenosis in the proximal sfa (20mm from origin of sfa), 90% severe stenosis noted few centimeters below the prior lesion, and approximately 70-80 mm lower, short stenosis of 75% was noted.In addition, moderate non-significant stenosis was noted in the right mid popliteal artery, right peroneal artery and anterior tibial artery, and occlusion was noted on proximal half of right posterior tibial artery.On the same day, 295 days post index procedure, 95% stenosis was noted in the adductor duct lesion that was predilated and placed a 6 mm x 40 mm eluvia drug eluting stent.Following, post-dilation was performed using 5 mm balloon.Post treatment, the final residual stenosis was noted to be 0% and good flow was noted.In addition, 50-60 % stenosis noted in right proximal sfa was treated by pre-dilation and drug coated balloon angioplasty using a 5 mm x 200 mm ranger drug coated balloon.Post different dilations, persistent significant stenosis was noted in the right mid sfa which was treated by placement of 6 mm x 40 mm eluvia drug eluting stent.On (b)(6) 2024, the event was considered resolved.On the same day, the subject was discharged from the hospital.
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