VersaCross Connect LAAC Access Solution

Additional Manufacturer Narrative

GOOD FAITH EFFORT ATTEMPTS TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT ARE IN PROGRESS. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND PERFORATION. A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A LAAC PROCEDURE. TRANSEPTAL PUNCTURE WAS PERFORMED UNDER TEE GUIDANCE. THE ORIENTATION OF THE TENDING ON THE SETPUM WAS AN IDEAL INFERIOR AND POSTERIOR. AFTER FIVE MINUTES OF CROSSING WITH THE VERSACROSS CONNECT SYSTEM, IT WAS NOTICED A PERICARDIAL EFFUSION ON AT THE LEVEL OF THE LEFT ATRIUM. IT SEEMS THAT THE PERFORATION HAD A VERY POSTERIOR WALL ORIENTATION MAKING IT VERY HARD TO PERFORM A PERICARDIAL DRAINAGE. HENCE, IT WAS DECIDED TO GO HEAD WITH A THORACOTOMY, AND A LAA WAS LITIGATE. THE SURGEONS OBSERVED A PERFORATION AT THE POSTERIOR WALL OF THE LA. THE PATIENT IS EXPECTED TO RECOVER FULLY. THE PERICARDIAL EFFUSION BECAME EVIDENT AFTER THE TRANSSEPTAL AND AFTER ADVANCING THE TRUSTEER SHEATH. NO DEVICE MALFUNCTIONS WERE REPORTED. TEE WAS USED AS IMAGE. THERE WAS NO PERICARDIAL EFFUSION NOTED PRIOR TO THE PROCEDURE.