Model Number 1973-03 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemia (1942)
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Event Date 11/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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A1 - patient identifier: (b)(6).A2 - age at time of event: 74 years old at the time of enrollment.
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Event Description
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Elegance clinical trial.It was reported ischemia occurred.The subject underwent treatment with the ranger drug-coated balloon and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was located in the left external iliac artery with 6mm proximal reference vessel diameter and 6.5mm distal reference vessel diameter with lesion length of 60mm with 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 7mm x 60mm ranger drug-coated balloon study device.Following post-treatment was performed by placement of 9mm x 60mm epic vascular self-expanding stent and the final residual stenosis was noted to be 30%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital, computed tomography angiography runoff showed significant stenosis in the left distal external iliac artery (eia) stent.However, no action was taken at that point of time.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, subject underwent angiography which revealed severe stenosis in left distal external iliac artery stent and new severe stenosis of the left proximal superficial femoral artery.Patency noted in bilateral renal arteries, common iliac arteries, internal iliac artery, common femoral artery, profunda femoral artery and 3 vessel runoffs to the foot.On the same day, 165 days post index procedure, severe stenosis noted in the left distal external iliac artery was treated by performing intravascular lithotripsy using 8mm x 30mm non-boston scientific balloon, followed by placement of 9mm x 40mm epic self-expanding stent which was post dilated using 8mm x 40mm sterling balloon.Subsequently, severe restenosis in the left proximal superficial femoral artery was treated by pre-dilation using 4.5mm x 40mm sterling balloon followed by drug coated balloon angioplasty using 6mm x 40mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 0% with no evidence of dissection and preserved runoff to the left foot.On the next day, the subject was discharged from the hospital as subject was deemed medically stable for discharge.The outcome of the event is considered to be ongoing.
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Manufacturer Narrative
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A1 - patient identifier: (b)(6).A2 - age at time of event: 74 years old at the time of enrollment.
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Event Description
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Elegance clinical trial it was reported ischemia occurred.The subject underwent treatment with the ranger drug-coated balloon and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was located in the left external iliac artery with 6mm proximal reference vessel diameter and 6.5mm distal reference vessel diameter with lesion length of 60mm with 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 7mm x 60mm ranger drug-coated balloon study device.Following post-treatment was performed by placement of 9mm x 60mm epic vascular self-expanding stent and the final residual stenosis was noted to be 30%.On the third day of (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital, computed tomography angiography runoff showed significant stenosis in the left distal external iliac artery (eia) stent.However, no action was taken at that point of time.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, subject underwent angiography which revealed severe stenosis in left distal external iliac artery stent and new severe stenosis of the left proximal superficial femoral artery.Patency noted in bilateral renal arteries, common iliac arteries, internal iliac artery, common femoral artery, profunda femoral artery and 3 vessel runoffs to the foot.On the same day, 165 days post index procedure, severe stenosis noted in the left distal external iliac artery was treated by performing intravascular lithotripsy using 8mm x 30mm non-boston scientific balloon, followed by placement of 9mm x 40mm epic self-expanding stent which was post dilated using 8mm x 40mm sterling balloon.Subsequently, severe restenosis in the left proximal superficial femoral artery was treated by pre-dilation using 4.5mm x 40mm sterling balloon followed by drug coated balloon angioplasty using 6mm x 40mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 0% with no evidence of dissection and preserved runoff to the left foot.On the next day, the subject was discharged from the hospital as subject was deemed medically stable for discharge.The outcome of the event is considered to be ongoing.It was further reported that on (b)(6) 2023 post treatment, the final residual stenosis was noted to be 0%.Subsequently, 80% severe restenosis in the left proximal superficial femoral artery (sfa).Post treatment, the final residual stenosis was noted to be 30%.On (b)(6) 2023, the event was considered to be resolved and the subject was discharged from the hospital as subject was deemed medically stable for discharge.
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Search Alerts/Recalls
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