GALAXY G3 GLM915020Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10886704080138), received between Mar 2, 2018 and Apr 16, 2026 — classified as 10 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (12 reports).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. May 16, 2019Class IITerminated

   Incorrect coil length on the label

   Z-2280-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.50MM X 2.00CM GALAXY G3 MINI (GLM915020 / 0482510S) WAS IMPEDED IN THE PROXIMAL SECTION OF THE ASSOCIATED MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 06-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE INDICATED THAT THE PROCEDURE WAS TARGETING THE LEFT MAIN CORONARY ARTERY (LMCA). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TIP OF THE COIL INTRODUCER WAS FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE DEVICE ADVANCEMENT. THE INFORMATION INDICATED THERE WAS NO DELAY IN THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 15-APR-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA MDR REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905076 ↗
• InjuryMar 9, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 MINI 1.5MM X 2CM (GLM915020/ 0912507S) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM. DURING THE PROCEDURE, THE USER REPORTED THE COIL COULDN¿T FIT INTO THE ANEURYSM (UNKNOWN REASON) AND THE COIL WAS RESHEATHED, HOWEVER, COULD NOT BE RESHEATHED IN A WAY THAT ALLOWED THE COIL TO BE USED AGAIN LATER. ANOTHER COIL (COMPETITOR BRAND) WAS USED AND THE PROCEDURE WAS COMPLETED. ON 25-FEB-2026, ADDITIONAL EVENT INFORMATION WAS RECEIVED. SUMMARY: PER THE INFORMATION PROVIDED, AN EXCELSIOR SL 10 MICROCATHETER WAS USED (STRYKER). REGARDING WHETHER THE EVENT RESULTED A PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS REPORTED, ¿THE ANEURYSM WAS PERFORATED, SO, WE LOST TIME IN USING ANOTHER COIL.¿ RELEVANT ANATOMICAL INFORMATION WAS REPORTED AS ¿NO RELEVANT TORTUOSITY.¿ RESULTING PATIENT CONSEQUENCES WERE REPORTED AS ¿MORE SUBARACHNOIDAL BLEEDING THAN HAD TO BE.¿ THE DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24546577 ↗
• MalfunctionAug 20, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  THE EVENT WAS REPORTED VIA A KEY MONITORING; DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE IN THE 63-YEAR-OLD FEMALE PATIENT, THE 1.50MM X 2.00CM GALAXY G3 MINI (GLM915020 / 30895986) WAS IMPEDED IN THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN TRIED TO RETRACT THE COIL AND IT WAS FOUND THAT THE COIL HAD UNRAVELED / STRETCHED. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER FROM THE PATIENT AND REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE COMPLAINT DEVICE AND A PROCEDURE IMAGE WERE INCLUDED IN THE COMPLAINT. THE PHOTO OF THE DEVICE WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM AND THE PROCEDURE IMAGE WILL UNDERGO INDEPENDENT PHYSICIAN REVIEW. ON 12-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT TARGET ANEURYSM IS ON THE INTERNAL CAROTID ARTERY (ICA) BED SEGMENT. THE ANEURYSM IS APPROXIMATELY 3MM, REGULAR SHAPED ANEURYSM. PER THE INFORMATION, A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COMPLAINT COIL HAD NOT BEEN WITHDRAWN AND REPOSITIONED. THERE WAS NO RESISTANCE BETWEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007692 ↗
• MalfunctionApr 1, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A LEFT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, A GALAXY G3 MINI 1.5MM X 2CM COIL (GLM915020, 30895987) WAS DELIVERED IN PLACE. FAULT LIGHT WAS ILLUMINATED, AND THE COIL COULDN'T BE DETACHED. A NEW DETACHMENT CONTROL BOX (DCB) AND AN ENPOWER CONNECTING CABLE WERE REPLACED, BUT THE COIL WAS STILL UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL FROM THE PATIENT AND REPLACED IT WITH A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 30878424), BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN RETRACTED THE REPLACED THE COIL AND SWITCHED TO ANOTHER BRAND COIL TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 30 MINUTES, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-MAR-2024 INDICATED THAT BOTH COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE TO THE COILS WHEN REMOVED FROM THE PATIENT. THE SPRING RING IS DAMAGED DURING RECOVERY, AND THE SPRING RING CANNOT BE FULLY RECOVERED INTO THE LEAD-IN SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011906 ↗
• MalfunctionJan 31, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 2CM COIL (GLM915020, 30878401) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE OTHER COIL, A GALAXY G3 MINI 1.5MM X 2CM (GLM915020, 30878401) WAS FOUND TO BE UNRAVELED/STRETCHED DURING PROCESS OF FILLING THE ANEURYSM. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614304 ↗
• MalfunctionJan 31, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 2CM COIL (GLM915020, 30878401) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE OTHER COIL, A GALAXY G3 MINI 1.5MM X 2CM (GLM915020, 30878401) WAS FOUND TO BE UNRAVELED/STRETCHED DURING PROCESS OF FILLING THE ANEURYSM. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614299 ↗
• MalfunctionDec 4, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 48-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COMPLAINT DEVICE, A 1.50MM X 2.00CM GALAXY G3 MINI COIL (GLM915020 / 30895979) FILLED IN THE ANEURYSM. THE SYSTEM READY LIGHT DID NOT ILLUMINATE WHEN THE COIL SYSTEM WAS CONNECTED VIA THE CONTROL CABLE TO THE DETACHMENT CONTROL BOX. AFTER SEVERAL ATTEMPTS, THE SYSTEM READY LIGHT STILL DID NOT ILLUMINATE. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND SWITCHED TO A COMPETITOR BRAND COIL TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ON 23-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED. IN RESPONSE TO THE QUESTION ABOUT THE INTENDED PROCEDURE / TARGET VESSEL, THE INFORMATION PROVIDED A PROCEDURE IMAGE WHICH IS PENDING INDEPENDENT PHYSICIAN REVIEW. THE INFORMATION INDICATED THAT THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER USED WAS A HEADWAY® 17 MICROCATHETER (MICROVENTION). THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. INFORMATION RELATED TO IF A PRE-DEPLOYMENT ELECTRICAL CHECK W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18262701 ↗
• MalfunctionJul 12, 2023Positioning Failure; Positioning Failure

  AS REPORTED VIA THE STERLING STUDY, A 66-YEAR-OLD FEMALE, UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT PERICALLOSAL ARTERY ANEURYSM ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4MM, DOME 3.7MM, MAXIMUM ANEURYSM DIAMETER 4.7MM, NECK SIZE 1.4MM, AND DOME-TO-NECK RATIO OF 2.6MM. THE PARENT VESSEL DIAMETER WAS 1.8MM. COIL EMBOLIZATION WAS PERFORMED SUCCESSFULLY WITH THREE (3) CERENOVUS COILS AND 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. TWO ADDITIONAL CERENOVUS COILS, A GALAXY G3 XSFT 2MM X 2CM (GLX120202/ 30566874) AND A GALAXY G3 MINI 1.5MM X 2CM (GLM915020/ 30768280) WERE ATTEMPTED TO BE USED DURING THE EMBOLIZATION PROCEDURE BUT WERE NOT IMPLANTED AS PER INFORMATION RECEIVED ¿THE COILS DIDN'T PENETRATE PROPERLY THE ANEURYSM¿ I.E., THERE WAS COIL POSITIONING DIFFICULTY WITH COIL HERNIATION. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17308361 ↗
• MalfunctionFeb 13, 2023Device Difficult to Setup or Prepare; Material Twisted/Bent; Positioning Problem; Device Difficult to Setup or Prepare; Material Twisted/Bent; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANEURYSM TO THE RIGHT POSTERIOR COMMUNICATING ARTERY CONFIRMED BY ANGIOGRAPHY, AN UNSPECIFIED MICROCATHETER (MC) WAS DELIVERED TO THE UPPER THIRD OF THE ANEURYSM. THE THREE UNSPECIFIED COILS WERE DELIVERED AND DETACHED SUCCESSFULLY. FINALLY, THE FOURTH AND LAST COIL, A GALAXY G3 MINI 1.5MM X 2CM (GLM915020, 30772759) WAS DELIVERED TO FILL THE ANEURYSM. THERE IS ONLY A LITTLE SPACE LEFT IN THE ANEURYSM, IT WAS FOUND THAT THE COIL CANNOT BE FILLED INTO THE ANEURYSM COMPLETELY AFTER MULTIPLE ADJUSTMENTS. FINALLY, DUE TO THE DEVIATION OF THE MICROCATHETER TIP, THE PHYSICIAN INTENDS TO RETRACT THE COIL AND ADJUST THE POSITION OF MICROCATHETER. IT WAS FOUND THAT THE DELIVERY WIRE COULD NOT BE RETRIEVED INTO THE INTRODUCER SHEATH, AFTER SEVERAL ATTEMPTS, IT STILL FAILED. THE PHYSICIAN TRIED TO DELIVER THE COIL TO THE MICROCATHETER AGAIN BUT FAILED. THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE KINKED/BENT. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362108 ↗
• MalfunctionJul 26, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MM X 2CM GALAXY G3 MINI COIL (GLM915020, 30624671) WAS BEING USED AS THE THIRD COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102963 ↗
• MalfunctionJul 1, 2022Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.50MM X 2.00CM GALAXY G3 MINI (GLM915020 / 30546459) WAS THE SECOND COIL USED. THE COIL BECAME KINKED DURING USE. THE PHYSICIAN RETRACTED THE COIL AND USED ANOTHER COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14894186 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 42-YEAR-OLD FEMALE ((B)(6)) WITH NO TARGETED MEDICAL HISTORY, EXCEPT BEING A SMOKER, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT ANEURYSM IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY ON (B)(6) 2021. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2021, THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.1MM, DOME 6.3MM, MAXIMUM ANEURYSM DIAMETER 6.3MM, NECK SIZE 1.9MM, AND THE DOME-TO-NECK RATIO OF 3.3MM. THE PARENT VESSEL DIAMETER WAS NOT DONE. THE FOLLOWING COILS WERE IMPLANTED VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC): ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/ 30532733), ONE 4MM X 12CM GALAXY G3 (GLY120412/30541491), ONE 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535/30546472), ONE 2MM X 4MM GALAXY G3 MINI (GLM920040/30558132), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/30558365), AND ONE 2MM X 2MM GALAXY G3 XSFT (GLX120202/L16466). ONE 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525/30541484) WAS USED, BUT NOT IMPLANTED. MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED A TOTAL OF THREE TIMES. HEPARIN WAS ADMINISTERED

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516819 ↗
• InjuryApr 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 71-YEAR-OLD MALE PATIENT WITH A HISTORY OF CLASS 2 OBESITY (BMI 35 KG/M2) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH HUNT & HESS GRADE 1 ON (B)(6) 2021. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.9MM, DOME 3.5MM, MAXIMUM ANEURYSM DIAMETER 5MM, NECK SIZE 2.4MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS SPECTRA COILS: A 5 MM X 15 CM GALAXY G3 (GLY120515 / 30513182), A 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L14664), A 3 MM X 6 CM GALAXY G3 XSFT (GLX120306 / 30490139), A 2 MM X 6 CM GALAXY G3 MINI (GLM920060 / 30392250), A 1.5 MM X 2 CM GALAXY G3 MINI (GLM915020 / L14683), AND A 2 MM X 4 CM (GLM920040 / 30379814) VIA AN SL-10® MICROCATHETER (STRYKER). MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED THREE TIMES DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED INTRAOPERATIVELY. 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 WITH 69% ANGIOSUITE PACKING DE

  Patient problems: Aneurysm

  MAUDE report 14078957 ↗
• MalfunctionMar 10, 2022Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL PUSHER WIRE ON THE 1.50MM X 2.00CM GALAXY G3 MINI (GLM915020 / 30392731) BECAME KINKED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. A PHOTO OF THE COMPLAINT WAS INCLUDED IN THE COMPLAINT FILE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 1.50MM X 2.00CM GALAXY G3 MINI, THE EMBOLIC COIL WAS OBSERVED IN A STRETCHED CONDITION INSIDE THE INTRODUCER. BASED ON THE PRODUCT ANALYSIS ON 10-MAR-2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727199 ↗
• MalfunctionDec 16, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 2CM COIL (GLM915020, 30558128) WAS BEING USED AS THE FIRST FILLING COIL DURING THE PROCEDURE. WHEN THE COIL WAS COMPLETELY FILLED IN THE ANEURYSM, IT CANNOT BE DETACHED AFTER CONNECTING DETACHMENT BOX AND A NEW CABLE. THE PHYSICIAN CHECKED BATTERY AND FOUND IT HAD ENOUGH POWER, REMOVED THE COIL OUTSIDE OF PATIENT BODY AND IT WAS FOUND TO BE DETACHED IN THE OPERATING TABLE. A COMPETITOR¿S COIL WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017669 ↗
• MalfunctionNov 18, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.50MM X 2.00CM GALAXY G3 MINI COIL (GLM915020 / 30532739) WAS THE THIRD (3RD) COIL IN THE PROCEDURE. THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED IN STRETCHED CONDITION. IT WAS REPORTED THAT THE PHYSICIAN USED ¿A SAME LIKE PRODUCT¿ AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841125 ↗
• InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF APPENDECTOMY AND INTRACRANIAL ANEURYSMS (2 TOTAL) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 1) ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 5.0MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 4CM GALAXY G3 XSFT (GLX120304 / L16812), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10499), TWO 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30360290), TWO 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10660), AND TWO 1MM X 3CM GALAXY G3 MINI (GLM910030 / K10700) VIA AN SL-10 MICROCATHETER (STRYKER). PER THE INFORMATION DOCUMENTED ON THE CASE REPORT FORM (CRF), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COIL WAS USED BUT NOT IMPLANTED. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. HEPARIN WAS ADMINISTERED DUR

  Patient problems: Aneurysm

  MAUDE report 12368690 ↗
• InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF APPENDECTOMY AND INTRACRANIAL ANEURYSMS (2 TOTAL) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 1) ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 5.0MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 4CM GALAXY G3 XSFT (GLX120304 / L16812), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10499), TWO 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30360290), TWO 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10660), AND TWO 1MM X 3CM GALAXY G3 MINI (GLM910030 / K10700) VIA AN SL-10 MICROCATHETER (STRYKER). PER THE INFORMATION DOCUMENTED ON THE CASE REPORT FORM (CRF), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COIL WAS USED BUT NOT IMPLANTED. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. HEPARIN WAS ADMINISTERED DUR

  Patient problems: Aneurysm

  MAUDE report 12368684 ↗
• InjuryAug 10, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, ACTIVE SMOKING, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND RHEUMATOID ARTHRITIS UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2020. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. A PIPELINE FLOW DIVERTER WAS IMPLANTED DUE TO INCREASE IN ANEURYSM SIZE ON (B)(6) 2021. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. MODIFIED RAYMOND-ROY CLASSIFICATION FOR THE TARGET ANEURYSM FOLLOWING RETREATMENT WAS CLASS II. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT SIDEWALL OF THE ICA WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.5MM, DOME 5.9MM, MAXIMUM ANEURYSM DIAMETER 5.9MM, NECK SIZE 3.0MM, AND DOME-TO-NECK

  Patient problems: Aneurysm

  MAUDE report 12302367 ↗
• MalfunctionAug 9, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A 3MM X 4MM WIDE NECKED ANEURYSM ON THE INTERNAL CAROTID ARTERY (ICA), THE 1.50MM X 2.00CM GALAXY G3 MINI COIL (GLM915020 / 30530838) COULD NOT BE ADVANCED WITHIN THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THE COIL WAS WITHDRAWN FROM THE PATIENT AND WAS OBSERVED TO BE UNRAVELED / STRETCHED AFTER IT WAS WITHDRAWN. IT WAS REPORTED THAT THE COIL WAS PURPOSELY DETACHED. ANOTHER 1.50MM X 2.00CM GALAXY G3 MINI COIL (GLM915020 / 30530838) WAS USED AS A REPLACEMENT AND THIS COIL ALSO BECAME IMPEDED IN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADJUST THE COIL BUT WAS NOT SUCCESSFUL; THE COIL WAS RETRACTED AND IT WAS OBSERVED THE COIL HAD STRETCHED. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. DURING THE COIL ADVANCEMENT THROUGH THE MICROCATHETER, THERE WAS RESISTANCE AT THE END OF THE MICROCATHETER. THERE WAS NO ANOMALY OBSERVED ON THE MICROCATHETER. THE ISSUE OCCURRED DURING THE COIL INSERTION / ADVANCEMENT THROUGH THE MICROCATHETER BEFORE THE COIL EXITED THE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294713 ↗
• MalfunctionJul 15, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE 1.50MM X 2.00CM GALAXY G3 MINI COIL (GLM915020 / 30530838) COULD NOT BE ADVANCED WITHIN THE CONCOMITANT MICROCATHETER. THE COIL WAS WITHDRAWN FROM THE PATIENT AND ANOTHER 1.50MM X 2.00CM GALAXY G3 MINI COIL (GLM915020 / 30530838) WAS USED AS A REPLACEMENT AND THIS COIL ALSO BECAME IMPEDED IN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADJUST THE COIL BUT WAS NOT SUCCESSFUL; THE COIL WAS RETRACTED AND IT WAS OBSERVED THE COIL HAD STRETCHED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178576 ↗
• MalfunctionJun 23, 2021Difficult to Advance; Difficult to Advance

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6) YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF HEADACHES UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) BIFURCATION ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN ANTERIOR CIRCULATION ANEURYSM IN THE LEFT ICA. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 4.0MM, DOME 3.5MM, MAXIMUM ANEURYSM DIAMETER 4.0MM, NECK SIZE 2.4MM, AND DOME-TO-NECK RATIO 1.5MM. THE PARENT VESSEL DIAMETER WAS 2.9MM. THE NEUROFORM ATLAS® STENT SYSTEM (STRYKER) STENT-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30470347), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / 30407098 & 30401363), AND ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30366403). A PHENOM¿ 17 MICROCATHETER (MEDTRONIC). PER THE INFORMATION DOCUMENTED IN THE CASE REPORT FORM (CRF), MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED ONCE DURING THE PROCEDURE. ADDITIONALLY, ONE 3.5MM X 7.5CM GALAXY G3 (GLY123575 / L17137) AND ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30392244) WERE USED BUT NOT IMPLANTED. HEPARIN WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051330 ↗
• MalfunctionJun 23, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM, A 1.5MMX2CM GALAXY G3 MINI COIL (GLM915020, 30404214) WAS USED AT THE END OF THIS PROCEDURE. THE INTRODUCER WAS INSERTED INTO A Y-CONNECTOR WHICH WAS CONNECTED TO THE HUB OF A SL10, STRYKER MICROCATHETER. THE DELIVERY WIRE ADVANCED APPROXIMATE 50 CM BUT THERE WAS A RESISTANCE FELT. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT BUT THERE WERE NO VISUAL ABNORMALITIES. THE PHYSICIAN TRIED AGAIN BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE CONTINUED. THERE WAS NO REPOT OF PATIENT INJURY. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND WITH A STRETCHED CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051212 ↗
• MalfunctionApr 13, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MM X 2CM GALAXY G3 MINI COIL (GLM915020, 30412527) DID NOT DETACH AFTER MORE THAN 10 TIMES OF DETACHMENT TRY. THE PHYSICIAN SUCCESSFULLY TOOK THE DEVICE OUT OF THE PATIENT'S BODY. THE DETACHMENT CABLE WAS CHANGED TWO TIMES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657203 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT 894-024) WITH A HISTORY OF BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT PCA ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 5.1MM, NECK SIZE 2.0MM, AND DOME-TO-NECK RATIO 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L16293), ONE 2MM X 2CM GALAXY G3 (GLY120202/L12097), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L12616), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L11355), AND ONE 1MM X 1CM GALAXY G3 MINI (GLM910010/L14466) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 24.09% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), THERE WAS NO REPORTED MICROCATHETER KICKBACK. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE =

  Patient problems: Aneurysm

  MAUDE report 11236986 ↗