VersaCross Connect LAAC Access Solution

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD A HYPOTENSION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED TO BE USED. DURING PROCEDURE, TEE CONFIRMING NO THROMBUS. CASE HAS PROCEEDED WITH THE TRANSSEPTAL PUNCTURE, AND THE VERSACROSS RF WIRE CROSSED INTO THE LEFT ATRIUM AS IF THERE WERE A PFO. IT WAS NEEDED TO WITHDRAW THE VERSACROSS WITH THE DOUBLE CURVE SHEATH BECAUSE IT WAS NOT POSSIBLE TO VISUALIZE IT ON THE LEFT SIDE. AT THAT POINT, ALL PRESSURES APPEARED NORMAL. THEN, IT WAS REMOVED THE VERSACROSS TO ATTEMPT THE TRANSSEPTAL PUNCTURE AGAIN. THIS TIME, THE VERSACROSS DILATOR WOULD NOT FULLY ADVANCE THROUGH THE DOUBLE CURVE, AND WHILE APPLYING FORCE, THE PHYSICIAN DAMAGED THE TIP OF THE DILATOR AND BENT THE VERSACROSS RF WIRE. WE THEN USED A SECOND VERSACROSS WITH A NEW CURVE AND WERE ABLE TO SUCCESSFULLY PERFORM THE TRANSSEPTAL PUNCTURE WITHOUT ISSUE AND IN A GOOD POSITION. BASED ON THE TEE MEASUREMENTS OF 27 MM, IT WAS DECIDED TO PROCEED WITH A 31 MM DEVICE AIMING FOR APPROXIMATELY 13 PER CENT COMPRESSION, GIVEN THE LIMITED DEPTH AND A HEALTHY LEFT ATRIAL PRESSURE OF 15 MMHG. UPON DEPLOYMENT, THE MEASUREMENTS WERE NOT AS EXPECTED, AND THE DEVICE WAS UNDER-COMPRESSED. AT THAT POINT, IT WAS DECIDED TO UPSIZE TO A LARGER DEVICE, THEN MOVED TO A 35 MM DEVICE, WHICH RESULTED IN EXCELLENT IMPLANTATION AND MET PASS CRITERIA. ONE HOUR POST PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE PATIENT WAS NOTED TO HAVE DEVELOPED A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS TO DRAIN FLUID AND THEN TRANSFUSED THIS BACK INTO THE PATIENT. AUTOTRANSFUSION WAS PERFORMED, AND THE BLOOD WAS DARK IN COLOR, WHICH LED THEM TO DETERMINE THAT IT ORIGINATED FROM THE RIGHT SIDE. THE PATIENT WAS TAKEN TO SURGERY WHERE A PERICARDIAL WINDOW WAS PERFORMED TO EVALUATE THE EFFUSION. NO SOURCE OF THE PERICARDIAL EFFUSION COULD BE IDENTIFIED DURING SURGERY. THE PATIENT REMAINS HOSPITALIZED RECOVERING FROM THIS EVENT AS THE PATIENT REQUIRED OPEN-HEART INTERVENTION. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT. THE DILATOR DID NOT PASS THROUGH THE DOUBLE CURVE ON THE SECOND TRANSSEPTAL ATTEMPT WITH THE FIRST VERSACROSS KIT. IT WAS THEN EXCHANGED FOR ANOTHER VERSACROSS AND A DIFFERENT DOUBLE CURVE WHICH CAUSED MALFUNCTION DURING PROCEDURE. THE VERSACROSS DEVICES WERE NOT INSIDE THE PATIENT'S BODY WHEN THE PATIENT COMPLICATION BEGAN.

Additional Manufacturer Narrative

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. A SEPARATED COMPLAINT FOR THE VERSACROSS DILATOR IS BEING SUBMITTED.