Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly.The pusher assembly was not returned for evaluation.Therefore, the root cause of the coil detachment or the reported advancement issue during the procedure could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod coils, pod packing coils (pod pc), and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully implanted two pod coils and three pod pcs into the target vessel using the lantern.After advancing a small part of another pod coil out of the lantern, the pod coil would not advance any further.The physician then decided to remove the pod coil and while removing, the pod coil unintentionally detached within the lantern.Therefore, the lantern containing the pod coil was removed.It was reported that the pod coil was then flushed out of the lantern.The procedure was completed using a new pod coil, three pod pcs, and the same lantern.There was no report of an adverse effect to the patient.
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