MICRUSFRAME MFR100611Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077855), received between Apr 28, 2020 and Dec 30, 2022 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 35-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPERTENSION (NOT CONTROLLED) AND MIGRAINES, UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 7MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7MM, NECK SIZE 1.0MM, AND DOME-TO-NECK RATIO OF 5.7MM. THE PARENT VESSEL DIAMETER WAS 4.5MM. PER THE CASE REPORT FORM (CRF) AND CLINICAL DATABASE, THE COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING THREE (3) CERENOVUS COILS: A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / 30686618), A 5MM X 10CM GALAXY G3 (GLY120510 / 30670811) AND A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30370441). THE COILS WERE DELIVERED AND IMPLANTED VIA A CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE PRINCIPAL INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DE

  Patient problems: Aneurysm

  MAUDE report 16078062 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BASED ON THE MODIFIED INFORMATION RECEIVED ON (B)(6) 2022, COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING COILS WERE IMPLANTED: AN 8MM X 16.1CM MICRUSFRAME 10 (MFR100816 / L15372), A 5MM X 15CM GALAXY G3 (GLY120515 / 30517632), A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / K10121), A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / L16158), A 5MM X 15CM GALAXY G3 (GLY120515 / K10721), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / K10380), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / L16495) VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGIN

  Patient problems: Aneurysm; Ischemia Stroke

  MAUDE report 15936929 ↗
• MalfunctionJul 8, 2022Separation Failure; Difficult or Delayed Separation; Separation Failure; Difficult or Delayed Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COMPLEX POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM COIL EMBOLIZATION PROCEDURE, THE FIRST MICRUSFRAME COIL, A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / K10236) WAS DEPLOYED, HOWEVER, AFTER IT WAS RESHEATHED, IT FAILED TO REDEPLOY EFFECTIVELY AND WAS REPLACED WITH ANOTHER MICRUSFRAME COIL OF THE SAME SIZE BUT FROM A DIFFERENT LOT NUMBER. THE 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / 30593190) FAILED TO DETACH TWO TIMES AND THEN IT WAS SUCCESSFULLY DEPLOYED ON THE THIRD ATTEMPT. THE REMAINDER OF THE COIL EMBOLIZATION WAS COMPLETED USING STRYKER FILLING COILS. THE REPORTED ISSUE RESULTED IN A 15-MINUTE PROCEDURE DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 28-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE FIRST MICRUSFRAME COIL WAS FROM LOT K10236. THE SECOND MICRUSFRAME FROM LOT 30593190 DID SUCCESSFULLY DETACH ON THE THIRD ATTEMPT AND WAS IMPLANTED IN THE TARGET ANEURYSM. THE ENPOWER DETACHMENT CONTROL BOX 2 (DCB 2) (DCB2000500 / LOT# UNKNOWN) WAS USED. THE ENPOWER CONTROL CABLE WAS USED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962705 ↗
• InjuryOct 8, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM IN A FEMALE PATIENT, A 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15688) WAS SAFELY POSITIONED INTO THE ANEURYSM SAC AS THE FIRST FRAMING COIL, BUT THE MICROCOIL FAILED TO DETACH. THE PHYSICIAN REPOSITIONED THE CONCOMITANT SL-10 45 (STRYKER) MICROCATHETER AND REDEPLOYED THE COIL. ONCE AGAIN, HE PRESSED THE DETACHMENT BUTTON WITH NO COIL DETACHMENT. THE PHYSICIAN DID THIS A TOTAL OF FOUR TIMES WITHOUT SUCCESS AND ULTIMATELY DECIDED TO REMOVE THE COIL FROM THE PATIENT. AT SOME POINT DURING THE ATTEMPT TO DETACH THE COIL, THE ENPOWER CONTROL CABLE (ECB00018200/30585092) WAS REPLACED, BUT THE ISSUE CONTINUED. THE PHYSICIAN BEGAN TO RETRACT THE COIL OUT OF THE ANEURYSM. HE GOT THE COIL ABOUT HALFWAY INTO THE MICROCATHETER WHEN IT FINALLY DETACHED. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE COIL INTO THE ANEURYSM SINCE THIS NOW WAS THE ONLY OPTION. THE LAST LOOP OF THE COIL KICKED THE CONCOMITANT MICROCATHETER OUT OF THE ANEURYSM RESULTING IN COIL PROTRUSION INTO THE BASILAR ARTERY. THE PATIENT WAS SCHEDULED FOR A HEART PROCEDURE LATER IN THE WEEK, SO PLACING THE PATIENT ON ANTICOAGULATION THERAPY AND L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599367 ↗
• MalfunctionAug 3, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION TARGETING A 12MM X 8MM MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, WHILE DEPLOYING THE 6MM X 11.9CM MICRUSFRAME 10 COIL (MFR100611 / L16500), THE LAST LOOP OF THE COIL WAS PUSHING ON THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) CAUSING THE MICROCATHETER TO RETREAT. THERE WAS NO DIFFICULTY WITH POSITIONING THE COIL IN THE TARGET LESION, THERE WAS NO ISSUE WITH THE COIL CONFORMING TO THE ANEURYSM WALL. IT WAS REPORTED THAT THE COIL WAS WITHDRAWN AND REPOSITIONING TWO TIMES. THE COIL WAS REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM. NO DAMAGE WAS NOTED ON THE COIL WHEN IT WAS REMOVED. THE EMBOLIC COIL AND ITS RESPECTIVE DEVICE POSITIONING UNIT (DPU) DID NOT PROTRUDE FROM THE COIL INTRODUCER. THE PHYSICIAN HAD THE SAME EXPERIENCE WITH THREE OTHER COILS: TWO 7MM X 13.9CM MICRUSFRAME 10 COILS FROM THE SAME LOT (L15689), AND A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / L16657). THE PHYSICIAN SWITCHED TO AXIUM COILS (MEDTRONIC) AND WAS ABLE TO DELIVER THE AXIUM COILS USING THE SAME SL-10® MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY SIGNIFICANT PROCEDURAL DELAY; THERE WAS NO REPORT OF ANY PATIENT ADVERS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359951 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6) MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020 REQUIRING REPEAT COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/L137

  Patient problems: No Code Available

  MAUDE report 10239845 ↗
• MalfunctionApr 28, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL COIL EMBOLIZATION, TWO A 4X5MM MICRUSFRAME COILS WERE USED SUCCESSFULLY AS THE FIRST AND SECOND COILS WITH A HEADWAY 17 MICROCATHETER (MC). HOWEVER, A 6MM X 15CM GALAXY G3 COIL (GLY120615, L16321), A 6MM X 11.9CM MICRUSFRAME10 COIL (MFR100611, L10198) AND A 6MM X 26CM MICRUSFRAME10 COIL (MFR100626, L10199) BECAME STUCK WITH THE MC. THE PHYSICIAN REMOVED THE COILS THROUGH THE MC AND COMPLETED THE PROCEDURE SUCCESSFULLY BY USING THE SAME MC AND A COMPETITOR¿S COIL. IT IS UNKNOWN IF THE EVENT RESULTED IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO PATIENT CONSEQUENCES. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE REPORTED EVENTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ALL THREE COILS WERE STRETCHED AFTER WITHDRAWING. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. FIRST, RESISTANCE WAS FELT AND THEN THE DEVICE WAS TOTALLY BEFORE FLUORO SAFE DISTANCE WAS SOMETHING 20 CM FROM RHV. THERE WAS NO NOTICE OF ANYTHING OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005327 ↗