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Device Problem
Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/12/2020 |
Event Type
malfunction
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Event Description
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(b)(6) clinical study.It was reported that the balloon over extended during inflation.In (b)(6) 2020, the index procedure was performed.The target lesion was in the right peroneal artery with 99% stenosis, proximal and distal reference vessel diameter was 3.25 mm and 3.0 mm respectively with a length of 60 mm.As a treatment, orbital atherectomy was performed.Post atherectomy, balloon angioplasty was attempted with sterling balloon but there was significant 'watermelon seeding' of the irregular balloon.The balloon was withdrawn and the lesion was treated with a 4.0 mm x 15 mm cutting balloon to pre-dilate the lesion at burst pressures with a 20% residual stenosis.Post pre-dilation, the lesion was further treated with placing a 3.5 mm x 80 mm study stent.Post dilation was performed with residual stenosis of 0%.
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Event Description
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Saval pivotal clinical study.It was reported that the balloon over extended during inflation.In (b)(6) 2020, the index procedure was performed.The target lesion was in the right peroneal artery with 99% stenosis, proximal and distal reference vessel diameter was 3.25 mm and 3.0 mm respectively with a length of 60 mm.As a treatment, orbital atherectomy was performed.Post atherectomy, balloon angioplasty was attempted with sterling balloon but there was significant 'watermelon seeding' of the irregular balloon.The balloon was withdrawn and the lesion was treated with a 4.0 mm x 15 mm cutting balloon to pre-dilate the lesion at burst pressures with a 20% residual stenosis.Post pre-dilation, the lesion was further treated with placing a 3.5 mm x 80 mm study stent.Post dilation was performed with residual stenosis of 0% it was further reported that prior treating the target lesion, the superficial femoral artery (non-target lesion) with 95% stenosis was treated with sterling balloon catheter.The orbital atherectomy was performed at low speed.A significant wire bias precluded failure speed.
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Search Alerts/Recalls
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