Description of Event or Problem · 0
ON AUGUST 29, 2024, A PHYSICIAN REPORTED TO NEOTRACT THE FOLLOWING: A PATIENT HAD GONE TO THE EMERGENCY ROOM WITH LOWER ABDOMINAL PAIN THE EVENING AFTER HIS UROLIFT PROCEDURE ON (B)(6) 2024. THE PATIENT WAS ADMITTED TO EMERGENCY DEPARTMENT AFTER A CT SCAN SHOWED A SMALL PELVIC HEMATOMA. AN INFERIOR VENA CAVA (IVC) FILTER WAS PLACED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2024. EMERGENCY DEPARTMENT DISCHARGED THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024, THE REPORTING PHYSICIAN TOLD NEOTRACT THAT THE PATIENT HAD DIED DUE TO A PULMONARY EMBOLISM (PE). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED BY NEOTRACT FROM THE REPORTING PHYSICIAN ON (B)(6) 2024: THE PATIENT HAD SUCCESSFULLY COMPLETED AN UNCOMPLICATED UROLIFT PROCEDURE ON (B)(6) 2024, WITH NO APPARENT COMPLICATIONS AND MINIMAL BLEEDING OBSERVED. AFTER COMPLETING THE UROLIFT, THE PHYSICIAN ALSO REMOVED KIDNEY STONES, AND A CATHETER WAS PLACED. THE PATIENT WAS 68 YEARS OLD WITH A PROSTATE SIZE OF 41CC. PROSTATE ANATOMY INCLUDED A HIGH MEDIAN BAR AND BULKY, ASYMMETRICAL TISSUE/LOBES THAT INDICATED THE USE OF AN ADVANCED TECHNIQUE CATHETER (ATC). THE PATIENT HAD BEEN HOSPITALIZED FROM (B)(6) 2024, FOR A PE AND HAD STARTED ELIQUIS TREATMENT, WHICH WAS STOPPED IN (B)(6) 2024 PRIOR TO THE UROLIFT PROCEDURE. ON SEPTEMBER 4, 2024, NEOTRACT WAS TOLD BY THE REPORTING PHYSICIAN THAT HE WAS UNCERTAIN ABOUT ANY CONNECTION BETWEEN THE UROLIFT PROCEDURE AND THE PATIENT¿S DEATH AND HE HAD NO WAY TO DETERMINE IF THE UROLIFT PROCEDURE CONTRIBUTED.