Items returned: - n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications: potential complications include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.Users and/or patients should report any serious incidents to the manufacturer and the competent authority of the member state or local health authority in which the user and/or patient is established.Detachment of the device 31.The detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.32.Verify that the rhv is firmly locked around the delivery device before attaching the detachment control device to ensure that the embolization device does not move during the connection process.33.Ensure that the delivery device gold connectors are clean and free from blood or contrast.If necessary, wipe the connectors with sterile water and dry before connecting.34.Insert the proximal end of the delivery device into the detachment control device.When the delivery device is properly connected, the light will flash green and an intermittent tone will be heard.35.Verify the embolization device position before pressing the detachment button.36.Push the detachment button.During firing, the light should be solid green and the beep should be continuous.37.Verify detachment by first loosening the rhv valve, then pulling back slowly on the delivery device and verifying that there is not embolization device movement.If the embolization device does not detach, push the detachment button again.If the device is still not detached, obtain a new detachment control device and attempt detachment up to two additional times.If it does not detach, remove the delivery device.38.Verify the position of the embolization device angiographically through the guide catheter.39.Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the embolization device remains within the microcatheter.The physician has the discretion to modify the device deployment technique based on the complexity and variation in embolization procedures.Any modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information in these instructions for use.Imaging review, p23-2283, vp scientific affairs, md, 6/2/2023: eight angiographic images are supplied.Image 1: 3d dsa, lateral view of aneurysm.Medium-sized acom aneurysm.Measurements have been taken, but the image is blurry and the numbers difficult to read.These are the best i can read: neck: 3 mm.Height: i cant read the numbers.Width: 2 different measurements at about 5 mm.Image 2: lateral subtracted dsa.Medium-sized oblong acom aneurysm with large bleb on the superior wall.Image 3: single shot lateral radiograph, no contrast.A web is positioned in the aneurysm.It is not detached and the microcatheter tip is at the web proximal marker.Image 4: single shot lateral radiograph, no contrast.The web has been partially (about 2/3) into the microcatheter.Image 5: single shot lateral radiograph, no contrast.The web has the same appearance as in image 4, but the pusher has been pulled back and is now separated from the base of the web.It is about 1 cm distal to the via proximal marker.Image 6: single shot lateral radiograph, no contrast.The web has almost completely been pushed out back into the aneurysm, but now has an hourglass shape.Image 7: single shot lateral radiograph, no contrast.The web is now completely out and physically separated from the pusher and via tip.Image 8: single shot lateral radiograph, with contrast.A web (presumably the second web described in the report) is in the aneurysm and in good position, at least on this single view.The reason for the sticky and then premature web detachment is not explained by or seen on the images provided.
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