The fda forwarded ostial corporation an mdr from a user facility indicating that one of the balloons for a flash ostial system otw device may have been damaged during use and "never held any pressure".There were no patient injuries reported in association with this event.At this time, the user facility has been unable to provide ostial corporation with any additional feedback regarding the reported event and has not indicated if the device used in this case is available for evaluation.Additional details from the user facility mdr report are provided below: intended procedure: five vessel fenestrated/branched- evar with pmeg zfen- p- 2- 26- 124-r including distal bifurcate zfen- d- 12 - 28- 91-c and stented fenestrations to the celiac, sma, right renal artery, left main renal artery, and stented branch to the left lower pole renal artery.Percutaneous access of bilateral common femoral arteries with preclosure of 20 fr sheath on the right and 14 fr sheath on the left.
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