EMBOZENE MICROSPHERES

Description of Event or Problem

A LITERATURE ARTICLE PUBLISHED ON 9-JAN-2026 AND RECEIVED BY VARIAN ON 15-JAN-2026 WAS REVIEWED. THE EVENT DESCRIBED IN THE ARTICLE OCCURRED AROUND 24-JUL-2023. THE ARTICLE DESCRIBES A PATIENT THAT UNDERWENT UTERINE FIBROID EMBOLIZATION FOR TREATMENT OF SYMPTOMATIC UTERINE FIBROIDS USING EMBOZENE MICROSPHERES SIZED 700 ¿M AND 900 ¿M. EIGHT DAYS FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED WITH VULVAR NECROSIS AND RIGHT SIDED GLUTEAL SKIN CHANGES, ACCOMPANIED BY NUMBNESS ALONG THE LATERAL ASPECT OF THE RIGHT LEG. THERE WAS ALSO PROGRESSION TO GLUTEAL NECROSIS OVER THE SUBSEQUENT SEVEN DAYS. CT AND MRI IMAGING DEMONSTRATED INFLAMMATORY CHANGES AND INFARCTION OF SUBCUTANEOUS FAT IN THE RIGHT BUTTOCK, CONSISTENT WITH NON-TARGET EMBOLIZATION. A MULTIDISCIPLINARY TEAM DETERMINED THAT THE FINDINGS WERE ATTRIBUTABLE TO EXTRAVASATION OF EMBOLIC MATERIAL INTO THE GLUTEAL REGION. THE PATIENT WAS TREATED WITH BROAD SPECTRUM INTRAVENOUS ANTIBIOTICS, NEUROPATHIC PAIN THERAPY, AND COORDINATED MANAGEMENT INVOLVING GYNECOLOGY, SURGERY, INTERVENTIONAL RADIOLOGY, PAIN MANAGEMENT, NEUROLOGY, AND TISSUE VIABILITY SERVICES. SURGICAL DEBRIDEMENT WAS PERFORMED FOR THE NECROTIC VULVAR TISSUE, RESULTING IN FULL HEALING. THE GLUTEAL NECROSIS RESOLVED WITH CONSERVATIVE MANAGEMENT. AT THREE-MONTH FOLLOW-UP, THE PATIENT WAS ASYMPTOMATIC.

Additional Manufacturer Narrative

UTERINE FIBROID EMBOLIZATION IS AN APPROVED CLINICAL INDICATION FOR THE EMBOZENE MICROSPHERES. REVIEW OF THE COMPLAINT INFORMATION, AND ALL AVAILABLE PROCEDURAL DOCUMENTATION CONFIRMED THAT EMBOZENE MICROSPHERES WERE USED IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE SELECTED PARTICLE SIZES WERE APPROPRIATE FOR THE INTENDED INDICATION, AND THE OPERATORS FOLLOWED IFU GUIDANCE BY EMBOLIZING ONLY THOSE VESSELS THAT COULD BE SAFELY ACCESSED. BASED ON ALL AVAILABLE INFORMATION, THE EVENT IS ATTRIBUTED TO A KNOWN PROCEDURAL RISK AND NOT TO A DEVICE DEFECT OR IFU NON-CONFORMITY. NO MALFUNCTION OR PERFORMANCE ISSUE RELATED TO THE DEVICE WAS IDENTIFIED. THE ADVERSE EVENTS DESCRIBED¿TISSUE ISCHEMIA, TISSUE NECROSIS, AND NON-TARGET EMBOLIZATION¿ARE RECOGNIZED RISKS OF THE INTENDED PROCEDURE AND ARE INCLUDED AMONG THE ANTICIPATED ADVERSE EVENTS LISTED IN THE IFU. EMBOZENE MICROSPHERES CONTINUE TO PERFORM WITHIN THEIR ESTABLISHED SAFETY AND PERFORMANCE PROFILE AND REMAIN IN CONFORMITY WITH THE RELEVANT REGULATORY REQUIREMENTS. NO CORRECTIVE OR PREVENTIVE ACTION IS INDICATED AT THIS TIME.