AVANTI

Description of Event or Problem

As reported, three 6F¿12F Mynx Control Venous vascular closure devices (VCD) were used to close venous access sites, and post-procedural bleeding was observed from the access sites five minutes after leaving the procedure suite. Pressure dressings were reapplied to the right groin, and a Neptune patch and Safeguard were applied to the left groin, after which no further bleeding was noted. The patient underwent pulsed field ablation under anesthesia. Venous access was obtained via two access sites in the right femoral vein and one access site in the left femoral vein. The physician reported proper use of the device. Two minutes of timer time was allowed for each device, followed by 10 minutes of manual pressure after device removal. Additional manual pressure was applied to the left access site for 3minutes due to tract oozing. The patient left the electrophysiology laboratory without active bleeding before subsequent bleeding was observed in the post-procedure unit. The procedure was performed using an antegrade approach. The deployer was Mynx certified. A Cordis Avanti sheath introducer was used. The vascular sheath introducer insertion angle was 45 degrees, and vessel suitability was verified on venography. Vessel tortuosity and the presence of peripheral vascular disease (PVD)/calcium at the puncture site were unknown. Heparin (46,000 units) was administered during the procedure, the patient was taking Eliquis without interruption, and 100 mg of protamine was administered at the end of the procedure. Activated clotting time (ACT) values were 135, 343, 394, and 377. The platelet count was 173. The target femoral access site had not been previously closed with a vascular closure device, there was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site, and there were no multiple stick attempts before intravascular access was achieved. Additional information received indicated that a figure-of-eight stitch was placed in the left femoral vein prior to discharge, and the patient returned the following week for suture removal. The devices were not returned because they did not fail during the procedure and were discarded.

Additional Manufacturer Narrative

Due to system limitations, section H6 required to input Type of Investigation, Investigation Findings, and Investigation Conclusions for an initial report. Pending additional information to complete investigation. Additional information is pending and will be submitted within 30 days upon receipt.