As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, medical records were provided and reviewed.Therefore, the investigation is confirmed for deployment issue, material deformation, positioning issue and perforation.However, the investigation is inconclusive for tilt.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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A review of the reported information indicates that model 2120f vena cava filter allegedly experienced malposition of device, perforation, deployment issue, material deformation and positioning problem.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) old male patients weight was not provided.
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