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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
Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
Injury
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Manufacturer Narrative
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A1: patient id: (b)(6) a2: patient age 83 years old at time of enrollment.
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Event Description
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Elegance clinical study it was reported that restenosis occurred, requiring hospitalization and intervention.On (b)(6)2024, the subject underwent treatment with two ranger drug coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to the right distal sfa, with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length of 90 mm, and 90% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to target lesion treatment with the study devices, lithotripsy and atherectomy were performed using non-boston scientific devices.Pre-dilation was performed by using a non-boston scientific cutting balloon and percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was then performed by dilation using study devices 5 mm x 80 mm and 5 mm x 120 mm ranger drug-coated balloons, followed by the placement of eluvia drug-eluting vascular stent system 6x100, 130 cm study device.Post treatment dilation was performed by using a non-boston scientific pta balloon, and the final residual stenosis was noted to be 20%.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.On (b)(6)2024, the subject was noted with symptoms related to restenosis in the right sfa and was hospitalized on the same day for further evaluation and treatment.The subject received medications at that time.Restenosis was noted in the right sfa and was treated by lithotripsy and was revascularized using drug coated balloon.The event was ongoing, and the subject was still hospitalized.
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Manufacturer Narrative
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A1: patient id: (b)(6).A2: patient age 83 years old at time of enrollment.
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Event Description
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Elegance clinical study it was reported that restenosis occurred, requiring hospitalization and intervention.On (b)(6) 2024, the subject underwent treatment with two ranger drug coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to the right distal sfa, with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length of 90 mm, and 90% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to target lesion treatment with the study devices, lithotripsy and atherectomy were performed using non-boston scientific devices.Pre-dilation was performed by using a non-boston scientific cutting balloon and percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was then performed by dilation using study devices 5 mm x 80 mm and 5 mm x 120 mm ranger drug-coated balloons, followed by the placement of eluvia drug-eluting vascular stent system 6x100, 130 cm study device.Post treatment dilation was performed by using a non-boston scientific pta balloon, and the final residual stenosis was noted to be 20%.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2024, the subject was noted with symptoms related to restenosis in the right sfa and was hospitalized on the same day for further evaluation and treatment.The subject received medications at that time.Restenosis was noted in the right sfa and was treated by lithotripsy and was revascularized using drug coated balloon.The event was ongoing, and the subject was still hospitalized.It was further reported that the restenosis was not related to the study devices.
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Search Alerts/Recalls
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