GALAXY G3 GLX120202Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886704077640), received between May 9, 2019 and Jan 30, 2024 — classified as 3 deaths, 13 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 2MM X 2CM XSFT (GLX120202/ 30513167) COIL WAS USED AS A SECOND COIL. WHEN PULLED FROM THE PACKAGING FOLDER, THE STOPPER OF THE GALAXY G3 XSFT COIL WAS FOUND TO BE SLIGHTLY BROKEN, BUT THE PHYSICIAN DECIDED TO USE IT BECAUSE THE DEFECT WAS SMALL AND COULD BE USED. ATTEMPTED TO INSERT THE COIL INTO THE UNSPECIFIED MICROCATHETER (MC), BUT COULD NOT BE DELIVERED WELL, SO THE GALAXY G3 XSFT COIL WAS RETRIEVED. REPLACED WITH ANOTHER NEW COIL WITH THE SAME PRODUCT CODE, WHICH COULD BE USED WITH NO PROBLEMS. A TOTAL OF 2 COILS WERE IMPLANTED, CONFIRMED TO STOP GASTROINTESTINAL HEMORRHAGE, AND THE PROCEDURE WAS COMPLETED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606546 ↗
• MalfunctionDec 13, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN APPROACHED TO THE LESION WAS MADE AND ATTEMPTED TO DETACHED A GALAXY G3 XSFT 2MM X 2CM COIL (GLX120202, 30513176), BUT ENERGIZATION ERROR OCCURRED AND REPLACED BOTH THE ENPOWERCONTROLCABLE AND THE GALAXY G3 XSFT COIL WITH ANOTHER NEW ONES. AFTER THAT, DETACHMENT COULD BE DONE WITH NO ISSUES. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319919 ↗
• MalfunctionAug 28, 2023Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / 30641975) ¿DEPLOYED ON ITS OWN.¿ THE COIL WAS BEING INSERTED INTO THE MICROCATHETER (UNSPECIFIED BRAND) AND IT BECAME PREMATURELY DEPLOYED / DETACHED WITHOUT ANY ACTION INITIATED ON THE DETACHMENT DEVICE. THE COIL WAS RETRIEVED FROM THE CATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ON 28-ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A MALE. THE INTENDED PROCEDURE / TARGET VESSEL IS NOT KNOWN. THE BRAND OF THE CONCOMITANT MICROCATHETER USED WAS UNKNOWN; BUT THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE COIL WAS REPLACED WITH A 2MM X 2.5CM COIL (BRAND UNSPECIFIED). THE REPORTED ISSUE DID RESULT IN AN APPROXIMATELY 10-MINUTE DELAY, WHETHER IT WAS CLINICALLY SIGNIFICANT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17636461 ↗
• 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 17308350 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (CNV_2017_01), A 51-YEAR-OLD FEMALE SUBJECT(B)(6) WITH A HISTORY OF CONTROLLED HYPERTENSION AND POLYCYSTIC KIDNEY DISEASE UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM IN THE BIFURCATION BRANCH OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) ON 06-DEC-2022. THE PATIENT¿S PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 5.0 MM, DOME 4.7 MM, MAXIMUM ANEURYSM DIAMETER 5.1 MM, NECK SIZE 1.3 MM, AND DOME-TO-NECK RATIO OF 3.6 MM. THE PARENT VESSEL DIAMETER WAS 1.5 MM. COIL EMBOLIZATION WAS PERFORMED WITH FIVE (5) CERENOVUS COILS: A GALAXY G3 4MM X 7CM (GLY120407/30508862), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/K10383), A GALAXY G3 XSFT 2MM X 2CM (GLX120202/30641974), A GALAXY G3 XSFT 2MM X 2CM (GLX120202/30641974) AND A GALAXY G3 XSFT 2MM X 2CM (GLX120202/ 30563817) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. A BALLOON CATHETER (BRAND NOT SPECIFIED) WAS ALSO USED, BUT NOT IMPLANTED. 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 MENTI

  Patient problems: Aneurysm

  MAUDE report 17281470 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY ((B)(6)), A 51-YEAR-OLD FEMALE (SUBJECT 485-059) WITH A HISTORY OF CONTROLLED HYPERTENSION AND POLYCYSTIC KIDNEY DISEASE UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM IN THE BIFURCATION BRANCH OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) ON (B)(6) 2022. THE PATIENT¿S PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 5.0 MM, DOME 4.7 MM, MAXIMUM ANEURYSM DIAMETER 5.1 MM, NECK SIZE 1.3 MM, AND DOME-TO-NECK RATIO OF 3.6 MM. THE PARENT VESSEL DIAMETER WAS 1.5 MM. COIL EMBOLIZATION WAS PERFORMED WITH FIVE (5) CERENOVUS COILS: A GALAXY G3 4MM X 7CM (GLY120407/30508862), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/K10383), A GALAXY G3 XSFT 2MM X 2CM (GLX120202/30641974), A GALAXY G3 XSFT 2MM X 2CM (GLX120202/30641974) AND A GALAXY G3 XSFT 2MM X 2CM (GLX120202/ 30563817) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. A BALLOON CATHETER (BRAND NOT SPECIFIED) WAS ALSO USED, BUT NOT IMPLANTED. 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 MENTIO

  Patient problems: Aneurysm

  MAUDE report 17281257 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (CNV_2017_01), A 51-YEAR-OLD FEMALE (SUBJECT 485-059) WITH A HISTORY OF CONTROLLED HYPERTENSION AND POLYCYSTIC KIDNEY DISEASE UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM IN THE BIFURCATION BRANCH OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) ON (B)(6) 2022. THE PATIENT¿S PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 5.0 MM, DOME 4.7 MM, MAXIMUM ANEURYSM DIAMETER 5.1 MM, NECK SIZE 1.3 MM, AND DOME-TO-NECK RATIO OF 3.6 MM. THE PARENT VESSEL DIAMETER WAS 1.5 MM. COIL EMBOLIZATION WAS PERFORMED WITH FIVE (5) CERENOVUS COILS: A GALAXY G3 4MM X 7CM ((B)(4) ), A GALAXY G3 XSFT 3.5MM X 7.5CM ((B)(4) ), A GALAXY G3 XSFT 2MM X 2CM ((B)(4) ), A GALAXY G3 XSFT 2MM X 2CM ((B)(4) ) AND A GALAXY G3 XSFT 2MM X 2CM ((B)(4) ) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. A BALLOON CATHETER (BRAND NOT SPECIFIED) WAS ALSO USED, BUT NOT IMPLANTED. 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 IN THE CRF. IMMEDIATE POST-PROCEDURE MODIFIED

  Patient problems: Aneurysm

  MAUDE report 17281218 ↗
• MalfunctionJun 12, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION FOR MAJOR AOETOPULMONARY COLLATERAL ARTERIES (MAPCA) POST PEDIATRIC PROCEDURE. AFTER MICROCATHETER WAS INSERTED TO IMA, THE GALAXY G3 XSFT 2MM X 2CM (GLX120202, 30670797) WAS APPROACHED AS A FIRST COIL. WHEN ATTEMPTED TO DETACH, IT COULD NOT. REPLACING THE ENPOWERCONTROLCABLE (ECB00018200, 30960241), BUT THE ISSUE CONTINUED. PULLED THE COIL OUTSIDE THE PATIENT, AND WAS ABLE TO DETACH. AFTER APPROACHING THE SECOND COIL AND ATTEMPTED TO DETACH, BUT IT COULD NOT BE DETACHED. THE ISSUE WAS RESOLVED BY REPLACING THE DCB2 CONTROL BOX, AND THE PROCEDURE WAS COMPLETED WITH ABOUT 10 COILS USED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS INTERNAL MAMMARY ARTERY. OTHER CONCOMITANT DEVICES ARE MARVEL MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106716 ↗
• InjuryApr 7, 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 05-JAN-20

  Patient problems: Aneurysm

  MAUDE report 16704327 ↗
• MalfunctionFeb 14, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 2MM X 2CM COIL (GLX120202, 30546466) WAS USED AS THE THIRD COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING THE DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO PULL IT OUT AND USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371246 ↗
• MalfunctionFeb 6, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COILING PROCEDURE FOR AN ANEURYSM, AFTER DEPLOYING GALAXY G3 XSFT 2MM X 2CM COIL (GLX120202, 30546466), THE PHYSICIAN TRIED TO RETRIEVE THE COIL IN ORDER TO PLACE AGAIN. HOWEVER, IT WAS NOT POSSIBLE BECAUSE THE COIL WAS NOT RESHEATHABLE. THE COIL WAS USED WITH A HEADWAY 17 MICROCATHETER (MC). THE COMPLAINT DEVICE WAS REPLACED WITH A NEW COIL. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305126 ↗
• MalfunctionJan 10, 2023Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR WIDE NECK MICROANEURYSM WHICH IS 2MM AT THE RIGHT INTERNAL CAROTID POSTERIOR COMMUNICATING ARTERY (ICPCA). AT FIRST, EMBOLIZATION WAS ATTEMPTED WITH A ALLOON ASSISTANCE, BUT THE NECK WAS WIDE, AND THE COIL CAME OUT. EVENTUALLY, EMBOLIZATION WAS COMPLETED WITH STENT PLACEMENT. A MICROCATHETER (EXSELSIOR SL10) AND A BALLOON CATHETER (SCEPTER XC 4-10) WERE INSERTED INTO A GUIDING CATHETER (FUBUKI 4FR DILATOR) AND THE EXSELSIOR SL10 WAS SET AT THE LOWER LEFT NECK AROUND 7: 00 ORIENTATION. A GALAXY G3 XSFT 2MM X 2CM COIL (GLX120202, 30404222) WAS INSERTED AND DELIVERED. THE PHYSICIAN ATTEMPTED TO HAVE THE COMPLAINT COIL ENTERED COMPLETELY BUT CAME OUT OF THE NECK. THE COMPLAINT COIL WAS TAKEN IN AND OUT ABOUT FIVE TIMES BUT REMOVED. AT SOME POINT RE-SHEATHING WAS IMPOSSIBLE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COMPLAINT COIL. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE IS A GUIDEWIRE (CHIKAI BLACK .014").

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129853 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 50-YEAR-OLD FEMALE PATIENT (B)(6) WITH A HISTORY OF SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM), UNDERWENT COIL EMBOLIZATION OF A RUPTURED MIDLINE ANTERIOR COMMUNICATING ARTERY (ACOA) BIFURCATION ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6MM, DOME 4MM, MAXIMUM ANEURYSM DIAMETER 4MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 2MM. COIL EMBOLIZATION WAS PERFORMED WITH TWO (2) CERENOVUS COILS: A 2MM X 2CM GALAXY G3 XTRASOFT (GLX120202/L12961) AND A GALAXY G3 XTRASOFT 4MM X 8CM (GLX120408/L12875) VIA A PHENOM 17 MICROCATHETER. 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 14.52% ANGIOSUITE PACKING DENSITY. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021 WITH AN MRS = 0. 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS PER

  Patient problems: Aneurysm

  MAUDE report 16087175 ↗
• MalfunctionJul 19, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 2CM GALAXY G3 XSFT COIL (GLX120202, 30504545) WAS BEING USED AS THE FOURTH COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051582 ↗
• 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 (B)(6) FEMALE (SUBJECT 01208-006) 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 ADMINIS

  Patient problems: Ruptured Aneurysm

  MAUDE report 14517063 ↗
• MalfunctionMay 10, 2022Entrapment of Device; Stretched; Failure to Advance; Entrapment of Device; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A PROCEDURE OF THE MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCAS), A SHEATH (4FR) WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND AN ANGIO CATHETER APPROACHED TO THE AORTA TO INSERT INTO THE RIGHT BRONCHIAL ARTERY. A CONCOMITANT MICROCATHETER (LEONISMOVE) WAS INSERTED INTO THE PATIENT AND ADVANCED TOWARD A SHUNT POINT. AFTER COIL EMBOLIZATION WAS DONE WITH COMPETITIVE COILS, A 2MM X 2CM GALAXY G3 COIL (GLX120202, 30532745) WAS INSERTED. HOWEVER, IT WAS UNABLE TO BE PUSHED AS THE COMPLAINT COIL COMES OUT FROM THE MICROCATHETER. IT WAS HIGHLY LIKELY THAT THE 2MM X 2CM WAS DELIVERED WITH THE TAIL OF THE FIRST COMPLETIVE COIL REMAINING AT THE TIP OF MICROCATHETER (MC), AND BOTH COILS WERE INVOLVED AT THE TIP OF MICROCATHETER. IT BECAME IMPOSSIBLE TO PRESS, SO WHEN THE PHYSICIAN TRIED TO REMOVE IT, BUT IT BECAME UNRAVELED. THE COMPLAINT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. EMBOLIZATION WAS RESUMED BY APPROACHING WITH MICROCATHETER AGAIN. AFTER SEVERAL COILS WERE PLACED, A 2.5MM X 5CM GALAXY G3 COIL (GLX122505, 30637472) WAS USED FOR ADDITIONAL EMBOLIZATION. THE COIL WAS INSERTED AND WOUND INTO SEVERAL WINDINGS, BUT THE WINDINGS PROTRUDED M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345516 ↗
• InjuryFeb 28, 2022Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. A (B)(6) FEMALE PATIENT WITH A HISTORY OF CONTROLLED HYPERTENSION, ANXIETY, AND DEPRESSION UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RUPTURED LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM WITH HUNT & HESS GRADE 2 ON (B)(6) 2021 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. NO ACTION WAS TAKEN. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 1.9MM, DOME 2.4MM, MAXIMUM ANEURYSM DIAMETER 2.4MM, NECK SIZE 2.6MM, AND DOME-TO-NECK RATIO OF 0.9MM. COIL EMBOLIZATION WAS PERFORMED WITH TWO 2MM X 2CM GALAXY G3 XSFT COILS (GLX120202 / 30474456) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. 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 50% ANGIOS

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 13625378 ↗
• InjuryFeb 28, 2022Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. A (B)(6) FEMALE PATIENT WITH A HISTORY OF CONTROLLED HYPERTENSION, ANXIETY, AND DEPRESSION UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RUPTURED LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM WITH HUNT & HESS GRADE 2 ON (B)(6) 2021 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. NO ACTION WAS TAKEN. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 1.9MM, DOME 2.4MM, MAXIMUM ANEURYSM DIAMETER 2.4MM, NECK SIZE 2.6MM, AND DOME-TO-NECK RATIO OF 0.9MM. COIL EMBOLIZATION WAS PERFORMED WITH TWO 2MM X 2CM GALAXY G3 XSFT COILS (GLX120202 / 30474456) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. 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 50% ANGIOS

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 13625310 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CARDIAC ARRHYTHMIA, CONTROLLED HYPERTENSION, ACTIVE SMOKING, LUNG CANCER, CLASS 3 OBESITY (BMI 42 KG/M2), AND INTRACRANIAL ANEURYSMS (TOTAL OF 4) UNDERWENT COIL EMBOLIZATION OF A RECURRENT UNRUPTURED LEFT ANTERIOR CEREBRAL ARTERY (ACA) ANEURYSM ON (B)(6) 2021. THE PATIENT EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTRA-ARTERIAL TIROFIBAN WAS ADMINISTERED, AND THE EVENT IS RESOLVING. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE SEVERITY OF THE EVENT WAS ENTERED AS MILD. PER THE PRINCIPAL INVESTIGATOR (PI), THE RELATIONSHIP OF THE EVENT TO THE STUDY DEVICE WAS CAUSAL. THE EVENT WAS CONSIDERED SERIOUS BECAUSE IT REQUIRED MEDICAL INTERVENTION. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH COILS ON (B)(6) 2020; THE ANEURYSM WAS RUPTURED AT THE TIME OF PRESENTATION. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2021 REVEALED AN UNRUPTURED LEFT ACA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS ANEURYSM HEIGHT 3.0MM, DOME 2.3MM, MAXIMUM ANEURYSM DIAMETER 3.0MM, NECK SIZE 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thromboembolism

  MAUDE report 13266770 ↗
• DeathDec 17, 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) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, SMOKING (PREVIOUS), AND ATHEROSCLEROSIS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 53.6 MM ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPIRED SECONDARY TO AAA RUPTURE 300 DAYS FOLLOWING THE PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA FOR ENDOLEAK REPAIR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. THE STUDY PROCEDURE OCCURRED 2,582 DAYS AFTER THE INITIAL EVAR OF AAA. A TOTAL OF 8 SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE LUMBAR ARTERY: THREE 2 MM X 2 CM GALAXY G3 XSFT (GLX120202/UNKNOWN LOT NUMBER), TWO 2 MM X 4 CM GALAXY G3 XSFT HEL (GLX120204/UNKNOWN LOT NUMBER), AND THREE 2 MM X 8 CM GALAXY G3 XSFT HEL (GLX120208/UNKNOWN LOT NUMBER). FLUOROSCOPY TIME WAS 33 MINUTES. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED FOUR DAYS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 13025358 ↗
• DeathDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, SMOKING (PREVIOUS), AND ATHEROSCLEROSIS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 53.6MM ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPIRED SECONDARY TO AAA RUPTURE 300 DAYS FOLLOWING THE PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA FOR ENDOLEAK REPAIR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. THE STUDY PROCEDURE OCCURRED 2,582 DAYS AFTER THE INITIAL EVAR OF AAA. A TOTAL OF 8 SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE LUMBAR ARTERY: THREE 2MM X 2CM GALAXY G3 XSFT (GLX120202/UNKNOWN LOT NUMBER), TWO 2MM X 4CM GALAXY G3 XSFT HEL (GLX120204/UNKNOWN LOT NUMBER), AND THREE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/UNKNOWN LOT NUMBER). FLUOROSCOPY TIME WAS 33 MINUTES. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED FOUR DAYS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 13025353 ↗
• DeathDec 17, 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 MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, SMOKING (PREVIOUS), AND ATHEROSCLEROSIS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 53.6MM ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPIRED SECONDARY TO AAA RUPTURE 300 DAYS FOLLOWING THE PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA FOR ENDOLEAK REPAIR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. THE STUDY PROCEDURE OCCURRED 2,582 DAYS AFTER THE INITIAL EVAR OF AAA. A TOTAL OF 8 SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE LUMBAR ARTERY: THREE 2MM X 2CM GALAXY G3 XSFT (GLX120202/UNKNOWN LOT NUMBER), TWO 2MM X 4CM GALAXY G3 XSFT HEL (GLX120204/UNKNOWN LOT NUMBER), AND THREE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/UNKNOWN LOT NUMBER). FLUOROSCOPY TIME WAS 33 MINUTES. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED FOUR DAYS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 13025352 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6) FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF ACTIVE SMOKING AND INTRACRANIAL ANEURYSM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2021 AND EXPERIENCED INTRAOPERATIVE ANEURYSM PERFORATION. BALLOON OCCLUSION WAS PERFORMED AS INTERVENTION, AND THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT IS RECOVERING FROM THE EVENT. THE EVENT WAS CLASSIFIED AS SEVERE. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS RELATED TO THE STUDY DEVICE. THE EVENT WAS CONSIDERED SERIOUS.

  Patient problems: Aneurysm

  MAUDE report 13010241 ↗
• MalfunctionNov 29, 2021Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 2MM X 2CM COIL (GLX120202, COULD NOT BE INTRODUCED INTO A PROWLER 14, J SHAPE MICROCATHETER (606151JX, 30404222) AFTER TRYING SEVERAL TIMES, THE DELIVERY WIRE DISLOCATED FROM THE TRANSPARENT SHEATH. THE COIL WAS THEREFORE DISMISSED. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT WAS SUCCESSFULLY TREATED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT OTHER CERENOVUS COILS WERE SUCCESSFULLY DELIVERED THROUGH MICROCATHETER; INTERVENTION WAS FINISHED AFTER THE REPORTED INCIDENT WITH NO FURTHER COILS BEING USED. THE DEVICE DID NOT ENTER THE MICROCATHETER, SO THERE WAS NO NEED TO REMOVE IT. THE PROCEDURE WAS FINISHED AFTER THE REPORTED INCIDENT, THEREFORE, THE MICROCATHETER WAS THEN REMOVED BUT NOT DIRECTLY AS A RESULT OF THE DAMAGED COIL. NO DAMAGE WAS NOTICED ON THE DEVICE AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883328 ↗
• MalfunctionJan 25, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN ANTERIOR COMMUNICATING INTRACRANIAL ANEURYSM EMBOLIZATION, A 2MM X 2CM GALAXY G3 XSFT (GLX120202, K10195) FAILED TO DETACH. IT WAS IMPOSSIBLE TO RELEASE IT. ANOTHER COIL OF A DIFFERENT SIZE WAS USED RESULTING IN A SLIGHT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THE SAME DETACHABLE CONTROL BOX (DCB) AND THE SAME CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE REPORTED SLIGHT DELAY OF THE PROCEDURE WAS NOT CLINICALLY SIGNIFICANT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. IT WAS NOT NECESSARY TO REMOVE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222406 ↗