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Model Number 24715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Reocclusion (1985); Vascular Dissection (3160); Restenosis (4576)
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Event Date 09/05/2018 |
Event Type
Injury
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Event Description
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(b)(6) study.It was reported that restenosis occurred.In (b)(6) 2018, clinical status assessment identified the patient's qualifying condition as rutherford category 3.Subsequently, the index procedure was performed.The target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, reference vessel diameter of 5mm, a length of 100mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation using 4mm x 150mm balloon.Post pre-dilatation, standard percutaneous transluminal angioplasty (pta) was performed with 5mm x 150mm sterling balloon to the target lesion.Following, grade a dissection was noted; however, no action was taken.Post dilatation was also performed.The patient was discharged as an outpatient.In (b)(6) 2018, the patient developed restenosis in the left sfa.No action was taken to treat the event.
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Event Description
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Uxa25530 ranger ii sfa study it was reported that restenosis occurred.In (b)(6) 2018, clinical status assessment identified the patient's qualifying condition as rutherford category 3.Subsequently, the index procedure was performed.The target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, reference vessel diameter of 5mm, a length of 100mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation using 4mm x 150mm balloon.Post pre-dilatation, standard percutaneous transluminal angioplasty (pta) was performed with 5mm x 150mm sterling balloon to the target lesion.Following, grade a dissection was noted however, no action was taken.Post dilatation was also performed.The patient was discharged as an outpatient.In (b)(6) 2018, the patient developed restenosis in the left sfa.No action was taken to treat the event.It was further reported that in (b)(6) 2022, the event was considered as recovered/resolved.
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Search Alerts/Recalls
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