Description of Event or Problem · 0
I AM A CARDIAC ELECTROPHYSIOLOGIST REPORTING A MORTALITY IN A PATIENT OF MINE WHO UNDERWENT AN UNCOMPLICATED IMPLANT OF A WATCHMAN FLX PRO (B)(6) 2024. ONE DAY LATER HE STARTED HAVING CHEST PAIN, DYSPNEA, PRESENTED TO EMERGENCY ROOM WITH FINDINGS CONCERNING FOR PERICARDITIS, BUT TROPONIN MILDLY ELEVATED. HE HAD RESPIRATORY DISTRESS AND WAS HYPOTENSIVE. CTA UNREMARKABLE FOR PE, AND WATCHMAN STILL IN THE LAA OSTIUM. A SMALL PERICARDIAL EFFUSION WAS ABNORMAL BUT NOT LARGE ENOUGH TO CAUSE SYMPTOMS. PATIENT WAS HOSPITALIZED, STARTED ON PERICARDITIS RX BUT FAILED TO RESPOND TO COLCHICINE, STEROIDS. PERICARDIAL EFFUSION WAS DRAINED, BUT HE WORSENED REGARDLESS. INTUBATED. ACUTE KIDNEY AND LIVER INJURY. ECHO SHOWED PROFOUND RV FAILURE, AND HE HAD A PEA ARREST (B)(6) 2024 AND PASSED. HIS CLINICAL COURSE WAS CONSISTENT WITH ACUTE MYOPERICARDITIS WITH ACUTE RV FAILURE. HE HAD NO VIRAL ILLNESSES PRIOR TO THIS, NO PERICARDIAL EFFUSION AT THE TIME OF IMPLANT TO LEAD TO PERICARDITIS. I AM CONCERNED THIS MAY REPRESENT AN ADVERSE REACTION TO THE NEW HEMOCOAT POLYVINYLIDENEFLUORIDE-HEXAFLUOROPROPYLENE (VDF-HFP) COATING ON THIS GENERATION DEVICE WHICH IS NEW COMPARED WITH PRIOR GENERATIONS. OF COURSE, REACTIONS TO OTHER COMPONENTS OF THE DEVICE ARE POSSIBLE AS IS CATASTROPHIC MYOCARDITIS FROM AN IDIOPATHIC SOURCE, HOWEVER IN MY OPINION, THIS IS HIGHLY SUSPICIOUS OF AN ADVERSE REACTION TO THE WATCHMAN. ACUTE CHANGE FROM 1 WEEK PRIOR.