The Angio-Seal Vascular Closure Device developed by St. Jude Medical is designed to secure hemostasis after femoral artery punctures, allowing for early patient mobility post-angiography. The device comprises an anchor (footplate), a string, and a collagen plug, all of which are bio-absorbable. The footplate is deployed inside the artery and pulled against the arterial wall with the string to close the arteriotomy site, while the collagen plug—situated outside the artery following the inner footplate—seals the puncture externally.
This user manual elaborates on the mechanism of the 6F STS plus version of the device and underscores the importance of correct deployment to avoid complications, such as arterial thrombosis, which can lead to lower limb ischemia. The manufacturer’s database (MAUDE) cites over 500 incidents of collagen plugs found within the vascular lumen post-deployment. The publication includes four case studies from a six-year period where patients experienced lower limb ischemia or numbness shortly after the deployment of the Angio-Seal device, three of whom necessitated surgical intervention to remove the erroneously placed collagen plug.
Moreover, the manual stresses that if brisk bleeding occurs when tension is applied to the Angio-Seal footplate during deployment, it signifies an incorrectly anchored footplate, and the collagen pack should not be deployed. A more vigorous pull should then be applied to reposition the footplate properly before attempting to deploy the collagen plug again. This advice is critical as deploying the plug before bleeding has ceased could result in the plug entering the vessel lumen, with potentially serious consequences.
The authors of the manual express that understanding the mechanism for intra-arterial placement of the collagen plug and the steps to prevent it are not widely reported. Through awareness and adapted procedure, the manual aims to educate and prevent the complication, as evidenced by their success in averting the issue in a fifth patient after acknowledging the complication.
References:
Chat: Powered By VoiceSphere