Correction: g4: on initial report, the date received by manufacturer was stated as march 8, 2023.This is a typo.The correct date is march 6, 2023.H5 : labeled for single use question was corrected to answer as yes.H8 usage of device was answered as initial use of device.Six (6) angiographic images are supplied for this investigation.They are all blurry and of poor quality.They are not labeled as to side, date or time.Two issues are described in this report (one in each ica).The review of the provided images is as follows: image 1: poor quality ica oblique roadmap with very little contrast material.A medium sized aneurysm is seen, possibly in the pcom area.A microcatheter with only a few mm of unopened web is seen at the neck of the aneurysm.Image 2: single shot unsubtracted lateral radiograph centered on skull base, no contrast.A well opened pipeline flow diverter spans from the high supraclinoid ica/proximal m1 to just below the ophthalmic segment.A web is seen adjacent to the pipeline, off the posterior wall of the supraclinoid ica.Image 3: different, ap-ish projection, of the same as xavier bad web 2.I see a web with a lot of skull bone superimposed.The image is not interpretable.Image 4: same as xavier bad web 2, but with some small amount of contrast injected.Image 5: single shot unsubtracted ap radiograph centered on skull base; contrast seen in left ica circulation.A web is seen end-on in the proximal 1/3 of the supraclinoid ica, as both distal and proximal markers are almost superimposed.Image 6: single shot unsubtracted lateral radiograph centered on skull base, no contrast.A second well opened pipeline is seen spanning from the high supraclinoid ica to just below the ophthalmic segment.Posterior to it is a second web device.The previously described contralateral web and pipeline are also seen on this image.The complication described is not explained by these images.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.
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