Manufacturers ref# (b)(4).Summary of investigational findings: the filter was deployed but tilted upon deployment and then perforated the caval wall.The filter was retrieved with a gtrs.The patient did not experience any pain or symptoms due to this occurrence.A single image from a venogram, with imaging date (b)(6) 2020, was provided and reviewed.The image illustrates a gunther tulip filter in the infra renal ivc.Curvature of the ivc was observed.The filter was observed to be tilted, and a primary filter leg was extended outside of the column of contrast, indicating penetration.The hook of the filter appeared to abut ivc wall.Furthermore, a tulip filter and parts of a gtrs set, including a loop system catheter, a pin vise, two non-cook stop cocks and a retrieval catheter was returned and evaluated in the complaint investigation.The retrieval system was kinked, and dents were observed at the tip of the retrieval catheter.The filter was inside the retrieval catheter and was easy to deploy.No nonconformance was found on the filter.Measurements of the anchors at the primary legs, the primary legs diameter, the secondary legs high, the eyes wide and the leaf wide were all in accordance to specifications.It is unknown how the implant procedure went prior to filter deployment, and if any difficulties occurred during the procedure that could have let to filter tilt.Additionally, it is possible that deployment of the filter in a curved segment of the ivc resulted in the filter tilting and then penetrating the ivc wall.The device history record was reviewed with no evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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