Model Number 24657 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Embolism/Embolus (4438)
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Event Date 10/14/2021 |
Event Type
Injury
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Event Description
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(b)(6) trial.It was reported that an embolism occurred during the treatment of the target lesion.The subject underwent treatment with ranger drug coated balloons and eluvia drug eluting stent on (b)(6) 2021 as a part of the (b)(6) trial.The target lesion was located in the entire length of right superficial femoral artery.The lesion had a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 300 mm.The lesion was 100% stenosed and classified as tasc ii d lesion.Prior to target lesion treatment, laser atherectomy was performed with a turbo-elite catheter.Pre-dilation was performed with a 4.0 mm x 220 mm sterling percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by dilatation with a 5.0 mm x 200 mm and a 6.0 mm x 200 mm ranger drug coated balloons.This was followed by a placement of 7.0 mm x 40 mm eluvia drug eluting stent.During the procedure, an embolism was noted in the target lesion.In response to the embolism, mechanical thrombectomy was performed and the complication was resolved.Post dilatation was performed with 6 mm x 40 mm mustang pta balloon and 5.0 mm x 220 mm sterling pta balloon.The final residual stenosis was noted to be 10% and thrombus was noted in the treated vessel at the end of the procedure.On (b)(6) 2021 the subject was discharged from the hospital on clopidogrel and other antiplatelet medication.There were no patient complications reported.
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Manufacturer Narrative
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Patient identifier: (b)(6).
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Manufacturer Narrative
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A1: patient identifier: (b)(6).B5: describe event or problem updated to reflect there was no thrombus noted at the end of the procedure.
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Event Description
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Elegance clinical trial: it was reported that an embolism occurred during the treatment of the target lesion.The subject underwent treatment with ranger drug coated balloons and eluvia drug eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was located in the entire length of right superficial femoral artery.The lesion had a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 300 mm.The lesion was 100% stenosed and classified as tasc ii d lesion.Prior to target lesion treatment, laser atherectomy was performed with a turbo-elite catheter.Pre-dilation was performed with a 4.0 mm x 220 mm sterling percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by dilatation with a 5.0 mm x 200 mm and a 6.0 mm x 200 mm ranger drug coated balloons.This was followed by a placement of 7.0 mm x 40 mm eluvia drug eluting stent.During the procedure, an embolism was noted in the target lesion.In response to the embolism, mechanical thrombectomy was performed and the complication was resolved.Post dilatation was performed with 6 mm x 40 mm mustang pta balloon and 5.0 mm x 220 mm sterling pta balloon.The final residual stenosis was noted to be 10% and no thrombus was noted in the treated vessel at the end of the procedure.On (b)(6) 2021 the subject was discharged from the hospital on clopidogrel and other antiplatelet medication.There were no patient complications reported.
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Search Alerts/Recalls
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