An operative report and fluoroscopic images were provided along with the implant coil.The implant was returned in 3 partial sections, although photos provided by the customer showed 4.The wire diameter was measured and found the filar diameter for the coil in the event were within specifications.The implant coil was stretched, and a partial section of the implant had gel attached to it.The pusher was not returned for evaluation.According a photo from the customer, the biggest section removed was not returned for evaluation.The fluoroscopic images and operative report were reviewed by the product safety physician.The images displayed a stretched filament that is highly consistent with the reported events and and a stretched, retained coil.The investigation of the returned components, as well as the customer supplied images, determined the information available is consistent with a stretched implant coil.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing tensile forces over specification during maneuvering or placement of the coil; however, the root cause could not be determined.Excessively stretched coil filaments may be difficult to visualize under normal fluoroscopy.
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