MICRUSFRAME MFR180915Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704078227), received between Jun 5, 2018 and Jun 8, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) SIDE WALL ANEURYSM ON (B)(6)2022. THE HUNT & HESS GRADE WAS 3, THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE TARGET ANEURYSM WAS AS FOLLOWS: HEIGHT 4.1MM, DOME 5.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS PERFORMED USING THREE (3) CERENOVUS COILS: A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / 30686615), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30483248), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / 30583817) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS DURING THE INDEX PROCEDURE. ON (B)(6)2023

  Patient problems: Aneurysm

  MAUDE report 17093009 ↗
• InjuryJun 5, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE PATIENT IS A (B)(6) FEMALE WHO PRESENTED WITH A THREE-WEEK HISTORY OF HEADACHES AND INTERMITTENT VISION LOSS IN THE LEFT EYE. DURING THE PROCEDURE WORKUP, THE PATIENT WAS FOUND TO HAVE A LARGE LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM THAT MEASURED APPROXIMATELY 14 MM. THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE FLOW-DIVERTER-ASSISTED COIL EMBOLIZATION PROCEDURE, AN SL-10 MICROCATHETER WAS ADVANCED OVER THE SYNCHRO 2 STANDARD WIRE AND POSITIONED WITHIN THE ANEURYSM, THE MICRO WIRE WAS REMOVED AND THE MICROCATHETER WAS CONNECTED TO CONTINUOUS HEPARINIZED SALINE FLUSH, THE MICRUSFRAME18 9 MM X 15.3 CM COIL ((B)(6)) WAS LOADED INTO THE MICROCATHETER AND ALLOWED TO FLUSH. THE COIL WAS DEPLOYED UNDER CONTINUOUS FLUOROSCOPIC GUIDANCE; IT WAS RETRACTED AND RE-DEPLOYED TWICE DUE TO THE CONCERN THAT LOOPS WOULD CONTINUE TO DROP INTO THE PARENT ARTERY. THE MICRUSFRAME COIL WAS FINALLY DELIVERED INTO A SATISFACTORY POSITION WHERE IT WAS DETACHED AND IMPLANTED. IT WAS REPORTED THAT BECAUSE THE COIL APPEARED TO BE MOBILE, THE DECISION WAS MADE NOT TO ADD ADDITIONAL COILS FOR FEAR THAT THEY WOULD CAUSE THE ORIGINAL COIL TO MIGRATE INTO THE PARENT ARTERY. WHEN THE MICROCATHETER WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569610 ↗