Description of Event or Problem · 0
PATIENT ARRIVED FOR A LEADLESS PACEMAKER INSERTION. PATIENT WAS NOT A CANDIDATE FOR TRADITIONAL PACEMAKER DUE TO AN AV GRAFT ON LEFT ARM, AND FUTURE PRESERVATION OF THE RIGHT VESSELS FOR AN AV GRAFT. PATIENT WAS PLACED UNDER CONSCIOUS SEDATION AND AN ABBOTT AVEIR DELIVERY CATHETER WAS INSERTED. THERE WAS DIFFICULTY IN INSERTING THE CATHETER DUE TO THE PATIENT'S ANATOMY. THE DEVICE WAS DEPLOYED, BUT THE READING INDICATED ABNORMAL IMPEDANCE AND A POTENTIAL PERFORATION. AN ECHOCARDIOGRAM (TEE) WAS PERFORMED AND INDICATED NO PERICARDIAL EFFUSION OR CARDIAC TAMPONADE. THE DEVICE WAS REMOVED, AS THERE WAS NO CAPTURE NOTED ON THE CARDIAC RHYTHM. PATIENT REMAINED HEMODYNAMICALLY STABLE. A SECOND ATTEMPT WAS MADE WITH A NEW DEVICE. ONCE THE DEVICE WAS IN THE RIGHT VENTRICLE, CONTRAST WAS INJECTED AND NO PERICARDIAL STAINING WAS NOTED. THE DEVICE FAILED TO RELEASE AND DEPLOY. THE SECOND DEVICE WAS REMOVED. THE THIRD ATTEMPT TO INSERT THE DEVICE, THE PATIENT BEGAN TO BECOME HEMODYNAMICALLY UNSTABLE. STAT ECHOCARDIOGRAM (TEE) WAS OBTAINED, AND A PERICARDIAL EFFUSION WAS NOTED. CPR WAS INITIATED AND ANOTHER INTERVENTIONAL CARDIOLOGIST AND CARDIOTHORACIC SURGEON ARRIVED FROM ACROSS THE HALL. A PERICARDIOCENTESIS PRODUCED A LARGE VOLUME OF BLOOD. THE CARDIOTHORACIC SURGEON PERFORMED AN EMERGENT STERNOTOMY AND REPAIRED A 1 CM APEX PERFORATION OF RIGHT VENTRICLE. DESPITE THE REPAIR, PROLONGED INTERNAL CARDIAC MASSAGE, REPEATED CARDIOVERSIONS, AND LARGE VOLUME BLOOD PRODUCT RESUSCITATION, THE PATIENT WAS NOT ABLE TO BE RESUSCITATED. DEVICE EXP#, REF#, LOT#, UDI, AVEIR 1: 2024-04-30, LSCD111, 8884312, (B)(4); AVEIR 2: 2024-04-30, LSCD111, 8884312, (B)(4); AVEIR 3: 2024-04-30, LSCD111, 8884312, (B)(4). REF REPORT: MW5144547.