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Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Occlusion (1984); Vascular Dissection (3160)
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Event Date 08/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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Event date is literature article published date percutaneous intervention for restoration of patency of occluded lower limb arteriovenous dialysis access indian heart journal (2017) vol.70 issue 3 pg 450-454 10.1016/j.Ihj.2017.08.015.If information is provided in the future, a supplemental report will be issued.
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Event Description
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This article reports on a (b)(6) female with ckd (chronic kidney disease) on maintenance dialysis twice weekly with uremic symptoms from the past 3 days.She had a saphenofemoral loop av fistula on the right lower limb.Left femoral arterial access was taken and 7 f arterial sheath (non-mdt) was inserted.Fistulography was done with 6f right catheter (non-mdt) after crossing over to the right superficial femoral artery.It showed complete occlusion of the venous outflow with normal arterial inflow segment.The fistula was hooked with 3.5 f right (non-mdt) catheter and 0.35 inch (non-mdt) j tipped wire was used to cross the obstruction.It was exchanged with 0.35-inch stiff wire (non-mdt) with the help of a non-mdt infusion catheter.The entire venous loop with the obstruction was sequentially dilated with 5 20 mm non-mdt balloon and 6 x 60 mm admiral balloon (medtronic-invatec) at 20 to 22 atm.Post procedure angiogram showed good opening of the proximal saphenous venous loop with good distal outflow.Immediate complication observed was extravasation of dye to subcutaneous tissues during manipulation of the guide wire however, the fistula was crossed successfully and dilated with balloons.Post balloon dilations venograms showed a spontaneous cessation of the dye extravasation, which precluded any further intervention to stop bleeding.At 6th month follow-up, the patient continued to have maintenance hemodialysis through the lower limb saphenofemoral fistula.The patient presented with delayed complication, namely re-occlusion at 9th month with subsequent failure to undergo dialysis.She was taken up for repeat intervention which failed possibly due to localized tear/dissection while negotiating the guidewire through the occluded segment.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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