250UM EMBOZENE 2ML COLORED - US

Additional Manufacturer Narrative

CORRECTION: H6 INVESTIGATION FINDINGS. ADDITIONAL INFORMATION H11: OUR INVESTIGATION OF THE REPORTED EVENT, INCLUDING A REVIEW OF ALL AVAILABLE PROCEDURAL DOCUMENTATION, CONFIRMED THAT EMBOZENE MICROSPHERES WERE UTILIZED IN ACCORDANCE WITH THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS PERFORMED FOR AN APPROVED CLINICAL INDICATION, THE SELECTED MICROSPHERE SIZE WAS APPROPRIATE, AND THE OPERATORS ADHERED TO IFU GUIDANCE BY EMBOLIZING ONLY VESSELS THAT COULD BE SAFELY ACCESSED. THE POST-PROCEDURE URINARY RETENTION AND PASSAGE OF NECROTIC TISSUE DESCRIBED IN THIS CASE ARE RECOGNIZED POTENTIAL OUTCOMES FOLLOWING PROSTATE ARTERY EMBOLIZATION AND ARE LISTED AMONG THE DEVICE¿S ANTICIPATED ADVERSE EVENTS. NO DEVICE MALFUNCTION, QUALITY CONCERN, OR DEVIATION FROM THE IFU WAS IDENTIFIED. THE PRODUCT CONTINUES TO MEET ITS ESTABLISHED SAFETY AND PERFORMANCE SPECIFICATIONS. ADDITIONALLY, THE TREATING PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL, WITH RESOLUTION OF PRE-PROCEDURE LOWER URINARY TRACT SYMPTOMS FOLLOWING REMOVAL OF THE OBSTRUCTING NECROTIC TISSUE.

Description of Event or Problem

SEE COMPLETED MW: (B)(4) MFR 3008262715-2025-00001.

Additional Manufacturer Narrative

NO SERIOUS INJURY WAS REPORTED. HOWEVER, THE PATIENT SOUGHT MEDICAL INTERVENTION DUE TO ADVERSE EVENTS (URINARY RETENTION DUE TO NECROTIC TISSUE EXPULSION) TO RESOLVE THE TEMPORARY IMPAIRMENT. THE ISSUE IS NOT CONSIDERED LIFE-THREATENING. IF LEFT UNRESOLVED, ADDITIONAL ADVERSE EVENTS COULD HAVE RESULTED. THIS EVENT IS RARE, BUT A KNOWN POTENTIAL COMPLICATION OF PROSTATE ARTERY EMBOLIZATION. THIS IS NOT AN ADVERSE EVENT DUE TO A MALFUNCTION OF THE DEVICE. THE DEVICE FUNCTIONED AS INTENDED.

Description of Event or Problem

PER THE UROLOGY CASE REPORTS JOURNAL PRE-PROOF ARTICLE, "CASE REPORT: ACUTE URINARY RETENTION DUE TO SLOUGHED TISSUE FOLLOWING PROSTATE ARTERY EMBOLIZATION", POST EMBOLIZATION WITH 250 UM EMBOZENE MICROSPHERES, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SUDDEN ONSET OF DIFFICULTY VOIDING [BLADDER] AND SUPRAPUBIC DISCOMFORT. THE EMERGENCY MEDICINE PHYSICIAN NOTED A GRAYISH SOFT TISSUE PROJECTING PER URETHRA DURING THE PHYSICAL EXAM IN ADDITION TO THE DISTENDED BLADDER AND CONSULTED THE UROLOGY TEAM. THE ON-CALL UROLOGY TEAM CONFIRMED THE AFOREMENTIONED FINDINGS AND SUCCESSFULLY EXTRACTED THE PROJECTING TISSUE WITH GENTLE TRACTION. THE TISSUE WAS APPROXIMATELY 10 CM IN LENGTH AND 1 CM IN WIDTH, WITH NO EVIDENCE OF ACTIVE BLEEDING PER URETHRA AFTER EXTRACTION. THE TISSUE WAS SENT OFF FOR HISTOPATHOLOGIC EVALUATION. THE PATIENT VOIDED IMMEDIATELY FOLLOWING THE EXTRACTION OF THE TISSUE FRAGMENT. CYSTOSCOPY REVEALED NECROTIC PROSTATIC FOSSA WITH NORMAL BLADDER MUCOSA, URETERAL ORIFICES IN NORMAL POSITION AND EFFLUX OF CLEAR URINE BILATERALLY. NO RESIDUAL NECROTIC TISSUE WAS FOUND IN THE BLADDER.