Denali Femoral System
Received Jul 27, 2026 · Event occurred Jul 3, 2026
Report 2020394-2026-01910 · MDR key 50021929
Device
Generic name
Vena Cava Filter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
DL950F
Lot number
GFKT1609
Product problems
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
On (b)(6) 2026, a patient was scheduled to undergo a percutaneous inferior vena cava filter implantation using a Denali filter. Prior to the procedure, the filter delivery rod suddenly broke while flushing the delivery system. The procedure was completed using another device. There was no patient contact.
Additional Manufacturer Narrative
H11: This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026. The catalog number identified in Section D4 has not been cleared in the US but is similar to the Denali Femoral System products that are cleared in the US. The PRO Code and 510 K number for the Denali Femoral System products are identified in D2 and G4. As the lot number for the device was provided, a review of the Device History Records was performed. The return of the sample is pending. However, a photo was provided for review. The investigation of the reported event is currently underway. Section A through F: The information provide 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.