The device was implanted in the patient.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Linked with: 2029214-2018-00782.If information is provided in the future, a supplemental report will be issued.
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Medtronic received report that pipeline flow diverter was used, with proximal connection to a previously implanted pipeline flow diverter.However, there was shortening of the stent resulted in an entry and re-entry zone in both the proximal and the distal part of the diseased vascular segment, so that extension in a distal direction with additional pipeline flow diverter was necessary and a fred 5.5/32 was then used in a proximal direction owing to the higher mesh density.The unruptured aneurysm was fusiform, in the right hemisphere, within the internal carotid artery (ica).The max diameter was 22mm with a dome height of 11mm.The distal parent artery was 5mm and 5.5 mm proximately.The aneurysm was 30% partially thrombosed prior to the ped placement.Post device placement, there was significant stasis and class 3 residual aneurysm.
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