A detailed review of all the lot history records related to lot number 164135 was performed; there were no issues identified that were deemed related to the complaint investigation.A detailed review of all the lot history records related to the lot number associated with this device was performed; there were no issues identified that were deemed related to the complaint investigation.A questionnaire was sent to the complaint site in order to obtain more procedural information and information on the events reported.However, no response from the site was returned despite multiple efforts made.A single image was provided to the investigation.These images were not original angiographic images but were taken via smartphone.It displayed the proximal sfa of the patient's left leg in which a biomimics 3d stent was shown.The radiopaque markers at the proximal and distal ends were identifiable and therefore it appears that the entire stent was fully deployed.The stent does not display any clear points of distortion or stent fracture.The image does show that roughly half of the stent on the proximal side has not expanded fully.The distal portion of the stent was expanded fully.It appeared that the proximal portion of the stent has not been post-dilated, however, this cannot be confirmed due to insufficient information received.The complaint investigation was categorised as "insufficient information" and a root cause category could not be assigned as a result.It could not be determined if the complaint was related to a deficiency of the device.
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