Description of Event or Problem · 1
ON (B)(6) 2019, PT WAS SCHEDULED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT WITH PROSTHETIC VALVE VIA PERCUTANEOUS FEMORAL ARTERY APPROACH. FOLLOWING ADMINISTRATION OF CONSCIOUS SEDATION, BILATERAL FEMORAL ARTERIAL AND NON-BIG SHEATH SIDE FEMORAL VENOUS ACCESS WAS OBTAINED VIA THE MODIFIED SELDINGER TECHNIQUE USING A 4F MICROPUNCTURE KIT INITIALLY, FOLLOWED BY 6F AND 7F INTRODUCER SHEATHS, AFTER WHICH 2 PERCLOSE SUTURES WERE DEPLOYED IN AN OPPOSING OBLIQUE FASHION (BUT NOT SECURED) IN THE BIG SHEATH SIDE FEMORAL ARTERY PRIOR TO EXCHANGE FOR A 12F INTRODUCER SHEATH. AT THIS POINT, THE MECHANICAL PROCEDURE TAVR, AS WELL AS THE RADIOLOGY C-ARM, NO LONGER RESPONDED TO THE CONTROLS, DESPITE MULTIPLE RE-BOOTS, AND ALL OTHER ATTEMPTS THAT COULD BE RECOMMENDED BY THE COMPANY REP OVER THE PHONE. THEREFORE, THE FEMORAL SHEATH WERE REMOVED BILATERALLY, WITH HEMOSTASIS ACHIEVED VIA EITHER CLOSURE DEVICE OR MANUAL COMPRESSION, AND THE REMAINDER OF THE PROCEDURE WAS ABORTED. THE PT RETURNED ON (B)(6) 2019 AND A SUCCESSFUL TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WAS PERFORMED. NO SIGNIFICANT AORTIC STENOSIS WITH NO SIGNIFICANT AORTIC INSUFFICIENCY NOTED FOLLOWING VALVE DEPLOYMENT. ELECTRICAL FAILURE OF THE GEO MODULE TILT ORT FLEXMOVE KIT. PART REPLACED BY PHILIPS HEALTHCARE TECH. FDA SAFETY REPORT ID# (B)(4).