MICRUSFRAME MFR100713Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704077879), received between Aug 3, 2020 and Nov 16, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2023Positioning Failure; Premature Separation; Positioning Failure; Premature Separation

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE 50-YEAR-OLD MALE SUBJECT WITH KNOWN LEFT MCA PREVIOUSLY SUB-TOTALLY CLIPPED ANTERIOR COMMUNICATING ARTERY ANEURYSM, RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH PAST MEDICAL HISTORY OF OBESITY WITH BMI OF 36 KG/M2. A HISTORY OF ALCOHOL USE DISORDER COMPLICATED BY WITHDRAWAL SEIZURE (LAST DRINK 7 YEARS AGO PER PATIENT). SEIZURE DISORDER AND TRAUMATIC SUBDURAL HEMATOMA (SDH) (07-JUN-2019), PATIENT FOUND TO HAVE UNRUPTURED MULTIPLE INTRACRANIAL ANEURYSM STATUS POST-CLIPPING OF THE LEFT MCA AND ACOM ANEURYSM COMPLICATED BY L-MEDIAL FRONTAL, L FRONTOPARIETAL AND L OCCIPITAL STROKES WITH CEREBRAL EDEMA WITH DCA IN 07/2023 WITH PRIOR SUBTOTAL CLIPPING OF THE ACOM PRESENTED WITH RESIDUAL AND PLAN FOR STENT COIL EMBOLIZATION. THE SUBJECT HAD PREVIOUS SURGICAL CLIPPING ON 04-JUN-2019, UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A MIDLINE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON 05-SEP-2023. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 6.0 MM, DOME 7 MM, MAXIMUM ANEURYSM DIAMETER 7 MM, NECK SIZE 6 MM, AND DOME-TO-NECK RATIO OF 1.2 MM. THE PARENT VESSEL DIAMETER WA

  Patient problems: Thromboembolism

  MAUDE report 18156604 ↗
• MalfunctionNov 15, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER COIL DETACHMENT OF A 7MM X 13.9CM MICRUSFRAME 10 COIL (MFR100713 / 30784504), THE PUSHER WIRE COULD NOT BE RETRIEVED FROM THE CONCOMITANT HEADWAY® DUO MICROCATHETER (MICROVENTION). THE MICROCATHETER AND THE PUSHER WERE RETRIEVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE FOLLOWING COILS WERE SUCCESSFULLY USED WITH THE CONCOMITANT HEADWAY® DUO MICROCATHETER (MICROVENTION): 11MM X 39CM COSMOS¿ 18 (MICROVENTION), 10MM X 36CM COSMOS¿ (MICROVENTION), AND A 9MM X 25CM GALAXY COIL. THE PROCEDURE WAS A RETREATMENT OF AN ANEURYSM THAT WAS TREATED TWO YEARS AGO, A BIG MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THERE WAS NO DAMAGE NOTED ON THE COMPLAINT DEVICE. THE INFORMATION INDICATED THAT AFTER COIL DETACHMENT, THE TIP OF THE PUSHER WIRE WAS STUCK AT THE TIP OF THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE. THE PROCEDURE ENDED PREMATURELY BECAUSE ¿THE MICROCATHETER WAS EVACUATED FROM THE ANEURYSM.¿ ANOTHER MICROCATHETER WAS NOT USED ¿BECAUSE THE MICROCA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145822 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6) MALE PATIENT WITH A HISTORY OF SMOKING (PREVIOUS) AND MANDIBULAR CANCER UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2019 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTEGRILIN/ASPIRIN WAS ADMINISTERED, AND NEUROFORM ATLAS STENT (STRYKER) WAS IMPLANTED. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2019 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 7.5MM, DOME 7.2MM, MAXIMUM ANEURYSM DIAMETER 7.5MM, NECK SIZE 5.9MM, AND DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 7MM X 13.9CM MICRUSFRAME 10 (MFR100713 / L13000), A 7MM X 21CM GALAXY G3 (GLY120721 / L13249), A 5MM X 10CM GALAXY G3 (GLY120510 / L12927), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / L13613), A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / L11233), AND A 2.00MM

  Patient problems: Thromboembolism

  MAUDE report 13101810 ↗
• MalfunctionAug 3, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION TARGETING A 12MM X 8MM MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, WHILE DEPLOYING THE 7MM X 13.9CM MICRUSFRAME 10 COIL (MFR100713 / L15689), 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: ANOTHER 7MM X 13.9CM MICRUSFRAME 10 COIL FROM THE SAME LOT (L15689), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L16657), AND A 6MM X 11.9CM MICRUSFRAME 10 COIL (MFR100611 / L16500). 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 PROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359940 ↗
• MalfunctionAug 3, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION TARGETING A 12MM X 8MM MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, WHILE DEPLOYING THE 7MM X 13.9CM MICRUSFRAME 10 COIL (MFR100713 / L15689), 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: ANOTHER 7MM X 13.9CM MICRUSFRAME 10 COIL FROM THE SAME LOT (L15689), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L16657), AND A 6MM X 11.9CM MICRUSFRAME 10 COIL (MFR100611 / L16500). 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 PROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359935 ↗