Model Number 1973-03 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 10/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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A1 - patient identifier: (b)(6).A2 - age at time of event: 51 years old at time of enrollment.
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Event Description
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Elegance clinical study.It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.8 mm proximal reference vessel diameter and 6.7 mm distal reference vessel diameter with lesion length 300 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 5 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study device of sizes, 6 mmx 200 mm and 6 mm x 100 mm ranger drug coated balloons and two 7 mm x 120 mm eluvia drug coated stents.Following post-dilation was performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 400 mm non-bsc balloon, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001 dissection of grade d was noted.The final residual stenosis was noted to be 0%.The dissection was caused due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons.In response to the complication, a bailout stent was placed.On the same day, the complication was resolved, and the subject was discharged on aspirin and clopidogrel.
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Event Description
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Elegance clinical study.It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.8 mm proximal reference vessel diameter and 6.7 mm distal reference vessel diameter with lesion length 300 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 5 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study device of sizes, 6 mmx 200 mm and 6 mm x 100 mm ranger drug coated balloons and two 7 mm x 120 mm eluvia drug coated stents.Following post-dilation was performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 400 mm non-bsc balloon, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001 dissection of grade d was noted.The final residual stenosis was noted to be 0%.The dissection was caused due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons.In response to the complication, a bailout stent was placed.On the same day, the complication was resolved, and the subject was discharged on aspirin and clopidogrel.It was further reported that on (b)(6) 2023 during the treatment of target lesion #001 dissection of grade d was noted due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons which was treated by placement of three 7 mm x 120 mm eluvia stents.Post dilation of stents were performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 40 mm non-bsc pta balloon.
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Manufacturer Narrative
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A1 - patient identifier: (b)(6).A2 - age at time of event: 51 years old at time of enrollment.
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Event Description
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Elegance clinical study: it was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.8 mm proximal reference vessel diameter and 6.7 mm distal reference vessel diameter with lesion length 300 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 5 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study device of sizes, 6 mmx 200 mm and 6 mm x 100 mm ranger drug coated balloons and two 7 mm x 120 mm eluvia drug coated stents.Following post-dilation was performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 400 mm non-bsc balloon, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001 dissection of grade d was noted.The final residual stenosis was noted to be 0%.The dissection was caused due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons.In response to the complication, a bailout stent was placed.On the same day, the complication was resolved, and the subject was discharged on aspirin and clopidogrel.It was further reported that on (b)(6) 2023 during the treatment of target lesion #001 dissection of grade d was noted due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons which was treated by placement of three 7 mm x 120 mm eluvia stents.Post dilation of stents were performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 40 mm non-bsc pta balloon.It was further reported that the target lesion #001 was in the right ostial superficial femoral artery, right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery.
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Manufacturer Narrative
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A1 - patient identifier: (b)(6).A2 - age at time of event: 51 years old at time of enrollment.
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Search Alerts/Recalls
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