VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION (DISPOSED BY THE FACILITY). IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. GOOD FAITH EFFORT ATTEMPTS TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT ARE IN PROGRESS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

A PERICARDIAL EFFUSION AND FISTULA OCCURRED AND PROCEDURE WAS ABORTED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. DURING A WATCHMAN A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A TRANSEPTAL PUNCTURE WAS PERFORMED USING THE VERSACROSS CONNECT LAAC ACCESS SOLUTION AND A TRUSTEER SHEATH. THE PHYSICIAN WAS PERFORMED THE TRANSEPTAL PUNCTURE UNDER FLUOROSCOPIC AND TEE GUIDANCE. THE PUNCTURE WAS PERFORMED AT A LOW-MID ASPECT OF THE FOSSA OVALIS - CONFIRMED BY BIPLANE TEE IMAGING. FOLLOWING RF DELIVERY, THE VERSACROSS WIRE WAS ADVANCED INTO THE LEFT ATRIUM AND IT WAS NOTED THAT THE WIRE WAS ENTERING THE ASCENDING AORTA. THE DILATOR AND SHEATH WERE NOT ADVANCED. THE WIRE WAS PULLED BACK INTO THE RIGHT ATRIUM, AND THE FISTULA WAS NOTED ON TEE. THIS FISTULA CLOSED AFTER 20 MINUTES AND REVERSAL OF HEPARIN WITH PROTAMINE. DURING THIS TIME THE PATIENT WAS NOTED TO HAVE A PERICARDIAL EFFUSION THAT WAS PERFORMED AND APPROXIMATELY 75 TO 100CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. THE PATIENT WAS STABLE AND THE EFFUSION STOPPED. THE PATIENT HAD AN ARTERIAL LINE PLACED FOR HEMODYNAMIC MONITORING, AND CHEST DRAIN IN PLACE. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT (ICU), AND A CT WAS SCHEDULED TO BE PERFORMED TO EVALUATE THE PATIENT FURTHER. THE PATIENT IS EXPECTED TO FULLY BE RECOVERED. THE BLOOD DRAINED FROM THE PERICARDIUM APPEARED TO BE HIGHLY OXYGENATED AND LIKELY FROM SYSTEMIC CIRCULATION.