Denali Femoral System

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE DENALI FILTER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE DENALI FILTER PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE ELECTRONIC PHOTO WAS PROVIDED AND REVIEWED. THE PHOTO SHOWS THE CLINICIAN HOLDING THE FILTER STORAGE TUBE. A FILTER WAS SEEN IN THE FILTER STORAGE TUBE, AND THE BLOOD RESIDUES ARE SEEN THROUGHOUT THE STORAGE TUBE. THE FILTER STORAGE TUBE NOTED TO BE BROKEN IN THE SHOWN PHOTO. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE BREAK AS THE SAFETY CAP OF THE FILTER V STORAGE TUBE WAS NOTED TO BE BROKEN. A DEFINITIVE ROOT CAUSE FOR THE REPORTED BREAK ISSUES COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN FEMORAL VEIN USING DENALI FILTER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FILTER STORAGE TUBE PLASTIC PIECE WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.