EARLY BIRD BLEED MONITORING SYSTEM

Description of Event or Problem

DURING THE LARGE-BORE 16F SHEATH REMOVAL AND WIRE EXCHANGE, THE FIRST EARLY BIRD LEVEL 1 INDICATION WAS TRIGGERED. SHORTLY THEREAFTER, THE PATIENT'S PRESSURE DROPPED SIGNIFICANTLY, AND IT WAS DETERMINED AT THAT TIME THAT THE PATIENTS RIGHT COMMON ILIAC WAS PERFORATED. DR. (B)(6) AND STAFF BEGAN APPLYING PRESSURE WHILE THEY ASSESSED. DR. (B)(6) THEN PLACED 3 ATRIUM ILIAC COVERED STENTS TO REPAIR THE RIGHT COMMON ILIAC; THIS TOOK ROUGHLY 8-10 MINUTES. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE ILIAC STENT PLACEMENT AND ASSESS THE SITUATION. UNDER FURTHER EXAMINATION, IT WAS DETERMINED THAT THERE WAS ANOTHER PERFORATION NEAR THE AORTIC BIFURCATION. AN AORTIC OCCLUSION BALLOON (24 MM TRUE BALLOON) WAS PLACED IN THE ABDOMINAL AORTA TO TRY AND STOP THE BLEEDING. DURING THIS TIME, CPR AND CHEST COMPRESSIONS WERE BEING PERFORMED. ROUGHLY 18 MINUTES AFTER THE EARLY BIRD INDICATION, THE PATIENT HAD EXPIRED. THE EARLY BIRD WAS RETRIEVED AND SHIPPED BACK TO SARANAS FOR SIGNAL EXAMINATION. SARANAS CHIEF MEDICAL OFFICER THEN DISCUSSED THE BLEEDING SIGNAL WITH DR. (B)(6). PATIENT INFORMATION WAS NOT MADE AVAILABLE TO SARANAS FOR THIS EVENT.

Additional Manufacturer Narrative

BASED ON THE INVESTIGATION AND DATA COLLECTED, IT WAS DETERMINED THAT THE EBBMS DID NOT CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY OR ILLNESS FOR THIS EVENT. THE EBBMS DEVICE FUNCTIONED AS INTENDED AS EVIDENCED IN THE DATA SHOWING THE EBBMS TRIGGERED AFTER DEVICE ACTIVATION INDICATING AN INTERNAL BLEED COMPLICATION. RELATED REPORT NUMBER: 3016011241-2022-00001.