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Model Number 45010 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism (1829); Vascular Dissection (3160)
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Event Date 05/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that a distal embolization and grade c dissection occurred.The patient was enrolled in the (b)(6) study with the patient identifier of (b)(6).As part of the study, the patient underwent treatment on (b)(6) 2019.The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion.The target lesion was treated with a jetstream pv atherectomy system console and a 2.1mm jetstream xc atherectomy catheter and there was 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis.During the index procedure, distal embolization of the target lesion was noted.The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms.Post embolization, blood flow was slow.The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting.The embolization was considered recovered/resolved on the same day.Also during this procedure, a grade c dissection of the target lesion was noted post pta.No action was taken to treat this event.At the time of reporting, the event was recovering/ resolving.No further complications were reported.
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Manufacturer Narrative
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Initial reporter facility name: (b)(6).
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Event Description
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It was reported that a distal embolization and grade c dissection occurred.The patient was enrolled in the jetstream china study with the patient identifier of (b)(6).As part of the study, the patient underwent treatment on (b)(6) 2019.The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion.The target lesion was treated with a jetstream pv atherectomy system console and a 2.1mm jetstream xc atherectomy catheter and there was 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis.During the index procedure, distal embolization of the target lesion was noted.The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms.Post embolization, blood flow was slow.The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting.The embolization was considered recovered/resolved on the same day.Also during this procedure, a grade c dissection of the target lesion was noted post pta.No action was taken to treat this event.At the time of reporting, the event was recovering/ resolving.No further complications were reported.It was further reported that the dissection occurred after pta, during the jetstream procedure, and the physician did not take action for this issue.No device issues were noted with the performance of the jetstream catheter, or the console, during the procedure.The physician believed that the distal embolization was caused by some soft thrombotic components in the lesion that easily peeled off when using jetstream.The embolism was successfully treated with the angiography and pta/stenting.The patient was returned safely to the ward after the procedure.
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Manufacturer Narrative
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Initial reporter facility name: (b)(6).
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Event Description
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It was reported that a distal embolization and grade c dissection occurred.The patient was enrolled in the jetstream china study with the patient identifier of (b)(6).As part of the study, the patient underwent treatment on (b)(6) 2019.The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion.The target lesion was treated with a jetstream pv atherectomy system console and a 2.1mm jetstream xc atherectomy catheter and there was 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis.During the index procedure, distal embolization of the target lesion was noted.The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms.Post embolization, blood flow was slow.The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting.The embolization was considered recovered/resolved on the same day.Also during this procedure, a grade c dissection of the target lesion was noted post pta.No action was taken to treat this event.At the time of reporting, the event was recovering/ resolving.No further complications were reported.It was further reported that the dissection occurred after pta, during the jetstream procedure, and the physician did not take action for this issue.No device issues were noted with the performance of the jetstream catheter, or the console, during the procedure.The physician believed that the distal embolization was caused by some soft thrombotic components in the lesion that easily peeled off when using jetstream.The embolism was successfully treated with the angiography and pta/stenting.The patient was returned safely to the ward after the procedure.It was further reported that the dissection occurred after pta, during the jetstream procedure, and the physician did not take action for this issue.No device issues were noted with the performance of the jetstream console during the procedure.
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Search Alerts/Recalls
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