A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded by the physician and not returned to the manufacturer for evaluation.An image document provided by the physician contains a fluoroscopic image that shows a partially coiled aneurysm.Additionally, the image shows what appears to be coil elongated and stretched out of the aneurysm, extending to the distal section of the parent artery.This fluoroscopic image and the photo image of a broken coil segment contained in the snared used to retrieve the elongated coil confirms the complaint.Without the return and evaluation of the physical device, the investigation is unable to determine if a condition existed with the device that would have caused or contributed to the reported complaint.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.
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It was reported during treatment of an aneurysm of the internal carotid artery, an embolization coil implant would not detach after multiple repositioning attempts.Upon retraction, the implant became stretched and broke.The broken pieces of the coil were retrieved using a clot retrieval device.There was no reported patient injury.
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