GALAXY G3 GLX120204Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704077749), received between Aug 5, 2019 and Jan 8, 2026 — classified as 2 deaths, 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN UNSPECIFIED MICROCATHETER WAS IN PLACE AND A GALAXY G3 XSFT HEL 2MM X 4CM (PRODUCT CODE GLX120204, LOT NUMBER 0942527S) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE (NON J&J) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003657 ↗
• MalfunctionJan 5, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER WAS IN PLACE AND A GALAXY G3 XSFT 4MM X 10CM COIL (PRODUCT CODE GLX120410, LOT NUMBER 30772783) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND NEW NON J&J COIL TO FILL THE ANEURYSM AND DETACHED THE COIL. WHEN THE DOCTOR FILLED THE ANEURYSM AGAIN WITH A THIRD COIL, A GALAXY G3 XSFT HEL 2MM X 4CM (PRODUCT CODE GLX120204, LOT NUMBER 30964875) AND DETACHED IT, THE THIRD COIL WAS UNABLE TO BE DETACHED. THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH NEW COIL (NON J&J) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-DEC-2025 INDICATED A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE SAME CABLE WAS NOT USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE EMBOLIC COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COILS DID NOT STRETCH OR WERE DAMAGED WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957626 ↗
• MalfunctionJan 7, 2025Stretched; Failure to Advance; Premature Separation; Stretched; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE FIRST COIL, A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30789556) WAS IMPEDED AT ABOUT 1/3 INTO THE MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE COIL HAD BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED IT WITH ANOTHER 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30964875) AND THIS COIL ALSO ENCOUNTERED THE SAME ISSUE AS THE FIRST COIL. IT WAS ALSO IMPEDED AND THEN BECAME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THIS SECOND COIL WITH A COIL FROM ANOTHER BRAND TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 24-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE TARGET WAS A 6MM X 4MM IRREGULAR ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. A 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. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COILS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097851 ↗
• MalfunctionJan 7, 2025Stretched; Failure to Advance; Premature Separation; Stretched; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE FIRST COIL, A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30789556) WAS IMPEDED AT ABOUT 1/3 INTO THE MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE COIL HAD BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED IT WITH ANOTHER 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30964875) AND THIS COIL ALSO ENCOUNTERED THE SAME ISSUE AS THE FIRST COIL. IT WAS ALSO IMPEDED AND THEN BECAME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THIS SECOND COIL WITH A COIL FROM ANOTHER BRAND TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 24-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE TARGET WAS A 6MM X 4MM IRREGULAR ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. A 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. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COILS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097849 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. THE 57-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, PREVIOUS SMOKER, AND TRANSIENT ISCHEMIC ATTACK (TIA) IN 2017 PRESENTED WITH AN UNRUPTURED ANEURYSM. THE PATIENT UNDERWENT COIL EMBOLIZATION ON (B)(6)2023. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE LEFT SIDEWALL ANTERIOR CIRCULATION: PARAOPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA): HEIGHT: 4.4MM, DOME: 5.2MM, MAXIMUM ANEURYSM DIAMETER: 5.2MM, NECK SIZE: 4.6MM, AND DOME-TO-NECK RATIO: 1.1MM. THE PARENT VESSEL DIAMETER WAS 4.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF A 4MM X 10CM GALAXY G3 (GLY120410 / 30618614), A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30656499), AND A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30571099) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). A FLOW DIVERTER, PIPELINE EMBOLIZATION DEVICE (MEDTRONIC), WAS ALSO IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLET

  Patient problems: Aneurysm

  MAUDE report 19274310 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. THE 57-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, PREVIOUS SMOKER, AND TRANSIENT ISCHEMIC ATTACK (TIA) IN 2017 PRESENTED WITH AN UNRUPTURED ANEURYSM. THE PATIENT UNDERWENT COIL EMBOLIZATION ON (B)(6) 2023. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE LEFT SIDEWALL ANTERIOR CIRCULATION: PARAOPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA): HEIGHT: 4.4MM, DOME: 5.2MM, MAXIMUM ANEURYSM DIAMETER: 5.2MM, NECK SIZE: 4.6MM, AND DOME-TO-NECK RATIO: 1.1MM. THE PARENT VESSEL DIAMETER WAS 4.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF A 4MM X 10CM GALAXY G3 (GLY120410 / 30618614), A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30656499), AND A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30571099) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). A FLOW DIVERTER, PIPELINE EMBOLIZATION DEVICE (MEDTRONIC), WAS ALSO IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLE

  Patient problems: Aneurysm

  MAUDE report 19274306 ↗
• MalfunctionMar 11, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30772774) FILLED IN THE ANEURYSM, BUT THE COIL ATTACHMENT POINT WAS NOT IN PLACE. THE PHYSICIAN RETRACTED THE COIL AND OBSERVED THAT THE COIL HAD BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 27-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM WAS A REGULAR ANEURYSM. NECK REMODELING WAS NOT USED. THE CONCOMITANT MICROCATHETER USED WAS AN SL-10® MICROCATHETER (STRYKER); 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. THERE WAS RESISTANCE DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER IN THE MID-SECTION OF THE MICROCATHETER. THE REPORTED ISSUE OCCURRED DURING ADVANCEMENT OF THE COIL INTO THE ANEURYSM. THE INFORMATION INDICATED THAT THE MICROCATHETER WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18880691 ↗
• MalfunctionJan 22, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, THE PHYSICIAN FILLED THE ANEURYSM WITH A GALAXY G3 XSFT HEL 2MM X 4CM COIL (GLX120204, 30772775). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE 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 18552862 ↗
• MalfunctionJul 31, 2023Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS FILLING THE ANEURYSM WITH COIL, AND THE COMPLAINT COIL, A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30762335) BECAME UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO REPORT OF ANY PATIENT INJURY / NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431284 ↗
• MalfunctionJan 20, 2023Device Difficult to Setup or Prepare; Difficult to Advance; Device Difficult to Setup or Prepare; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A SUBARACHNOID HEMORRHAGE (SAH), THE RE-SHEATHING TOOL FOR A GALAXY G3 XSFT HEL 2MM X 4CM COIL (GLX120204, 30478873) FAILED TO RE-SHEATH. THE SAME SIZE AND LENGTH OF ANOTHER COIL WAS IMMEDIATELY OPENED FOR THE PHYSICIAN TO CONTINUE WITH THE COILING PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT RESISTANCE WAS ENCOUNTERED DURING THE INITIAL ADVANCEMENT OF COIL THAT REQUIRED RESHEATHING. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHER (MC). THERE WAS NO DAMAGE OBSERVED ON THE SHEATH INTRODUCER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE TARGET SITE WAS THE ANTERIOR COMMUNICATING ANEURYSM ACCESSED FROM THE RICA. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND TO BE SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16217965 ↗
• 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) 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 13025376 ↗
• 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) 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 13025360 ↗
• MalfunctionApr 15, 2021Device Difficult to Setup or Prepare; Difficult to Advance; Device Difficult to Setup or Prepare; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE INTRODUCER SHEATH OF A 2MM X 4CM GALAXY G3 XSFT HEL COIL (GLX120204, 30371925) COULD NOT BE REMOVED AFTER COIL INTRODUCTION INTO THE UNSPECIFIED MICROCATHETER (MC). IT WAS ALSO REPORTED THAT THE RESHEATHING TOOL COULD NOT BE MOVED/UNLOCKED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO RECOGNIZED PACKAGING ISSUES. AFTER THE INTRODUCER WAS SEATED IN THE HUB, THE USER HELD THE TAB AND THE DELIVERY HUB WITH ONE HAND AND SLIDE THE ZIPPER TO THE STOPPER TO AVOID EXPOSING THE DELIVERY TUBE OR COIL. IT WAS VISUALLY CONFIRMED THAT THE COIL WAS ENTERING THE INFUSION CATHETER IN A STRAIGHT LINE AND THAT THE BLUE FLEXIBLE SECTION OF THE DELIVERY TUBE WAS WILL WITHIN THE INFUSION CATHETER HUB AND THAT THE ZIPPER ON THE COIL INTRODUCER WAS ADJACENT TO THE STOPPER TO PROPERLY COMPLETE THE COIL INTRODUCTION. THE USER FIRMLY HELD THE EXPOSED PORTION OF THE DELIVERY TUBE WITH ONE HAND AND SIMULTANEOUSLY GRASP THE INTRODUCER JUST DISTAL TO THE STOPPER WITH THE OTHER HAND AND SLIDE THE COIL INTRODUCER PROXIMALLY ALONG THE DELIVERY TUBE UNTIL THE COIL INTRODUCER STRIPPED ITSELF FROM THE DELIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670677 ↗
• InjuryDec 2, 2020Deformation 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

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, CONTROLLED HYPERLIPIDEMIA, MYOCARDIAL INFARCTION (MI), SUBARACHNOID HEMORRHAGE SECONDARY TO RUPTURED TARGET ANEURYSM ((B)(6) 2019), AND BENIGN PROSTATIC HYPERPLASIA (BPH) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT BASILAR ARTERY ANEURYSM ON (B)(6) 2020. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH UNSPECIFIED COILS ON (B)(6) 2019. 180-DAY (6-MONTH) FOLLOW-UP MAGNETIC RESONANCE ANGIOGRAPHY (MRA) PERFORMED ON (B)(6) 2020 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. RETREATMENT OF THE TARGET ANEURYSM WAS SUBSEQUENTLY PERFORMED DUE TO RESIDUAL NECK ON (B)(6) 2020. TWO COMPETITOR COILS WERE IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS OR STUDY DEVICE DEFICIENCIES. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020, REVEALED AN UNRUPTURED BASILAR ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.6MM, DOME

  Patient problems: Aneurysm

  MAUDE report 10936370 ↗
• MalfunctionNov 19, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 4CM GALAXY G3 XSFT HEL COIL (GLX120204, L12391) WAS BEING USED AS THE THIRD COIL TO BE IMPLANTED. AN EXCELSIOR SL-10 45 MICROCATHETER (MC) WAS USED AND THE COIL WAS EASILY INSERTED INTO THE PROXIMAL THIRD OF THE MC WITHOUT RESISTANCE. HOWEVER, IT THEN BECAME ¿STUCK¿ IN THE MC. AFTER WITHDRAWAL, THE COIL WAS STRETCHED. ALL OTHER COILS, INCLUDING THOSE SUBSEQUENTLY INTRODUCED/IMPLANTED, PASSED THROUGH THE MICROCATHETER WITHOUT ANY PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10868797 ↗
• InjuryMay 26, 2020Adverse 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 (B)(6)) WITH A HISTORY OF CONTROLLED HYPERTENSION AND APICAL HYPERTROPHIC CARDIOMYOPATHY UNDERWENT COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT MCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 4.3MM, MAXIMUM ANEURYSM DIAMETER 5.7MM, NECK SIZE 3.4MM, AND DOME-TO-NECK RATIO 1.3MM. PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 5MM X 15CM GALAXY G3 (GLY120515/L12907), ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L15707), AND ONE 2MM X 4CM GALAXY G3 XSFT HEL (GLX120204/L11837) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 30% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED ONE TIME DURING THE PROCEDURE (PENDING CLARIFICATION). IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPL

  Patient problems: Infarction, Cerebral

  MAUDE report 10086867 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR CEREBRAL ARTERY (ACA) BIFURCATION ANEURYSM ON (B)(6) 2019 AND EXPERIENCED INTRAOPERATIVE ANEURYSM RE-RUPTURE AFTER PLACING A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/L13753) COIL. THE RUPTURE RESOLVED ON THE SAME DAY WITH TEMPORARY BALLOON OCCLUSION AND FURTHER COILING. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS MODERATE IN SEVERITY AND WAS POSSIBLY RELATED TO THE STUDY DEVICE. THERE WAS ALSO A THROMBOEMBOLIC EVENT AT THE NECK OF THE ANEURYSM (AT THE TRANSITION OF THE RIGHT ANTERIOR COMMUNICATING ARTERY AND THE A2 SEGMENT OF THE LEFT ACA). THE PATIENT WAS ASYMPTOMATIC (ONLY OBSERVED ANGIOGRAPHICALLY) AND INTEGRILIN IIB IIIA WAS ADMINISTERED FOR 24-HOURS. ON (B)(6) 2019, ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM AT THE LEFT ACA BIFURCATION. THE ANEURYSM HEIGHT WAS 2.0MM AND DOME WAS 3.2MM. THE MAXIMUM ANEURYSM DIAMETER WAS 4.4MM, NECK SIZE WAS 3.1MM AND DOME-TO-NECK RATIO WAS 1.0MM. THE PARENT VESSEL DIAMETER WAS 2.5MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L13761), ONE 2.5MM X

  Patient problems: Thromboembolism

  MAUDE report 9751456 ↗
• MalfunctionDec 3, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM OF ROUNDABOUT 2MM, THE FIRST COIL WAS TOO BIG, THEN A 2MM X 4CM (GLM920040, L11688) GALAXY G3 MINI WAS CHOSEN. IT WAS PERFECTLY CONFIGURATED IN THE ANEURYSM, SO THEY WANTED TO DETACH, HOWEVER, THE SYSTEM DID NOT DETACH WHEN USING A ENPOWER DCB 2 (DCB2000500, L12008) AND AN ENPOWER CONTROL CABLE (ECB00018200, L11342). THEY USED ANOTHER ENPOWER DCB 2 (DCB2000500, L12008) AND ANOTHER ENPOWER CONTROL CABLE (ECB00018200, L11342, BUT IT DID NOT DETACH. A 1MM X 1CM GALAXY G3 MINI (GLM910010, L11221) WAS ATTEMPTED TO BE DETACHED BUT FAILED. AND A 1.5MM X 2CM GALAXY G3 MINI (GLM915020, L12474) ALSO FAILED TO DETACH. IN TOTAL THEY TRIED 3 DIFFERENT COILS, ALL OF THEM DID NOT DETACH OR DID NOT SHOW THE CONNECTION SIGNAL. THEY CHANGED THE CABLES AND BOXES, BUT NOTHING WORKED. IN TOTAL TWO DCB AND TWO CABLES WERE USED. THE PROCEDURE WAS COMPLETED WITH COMPETITOR¿S COILS. THERE WAS NO REPORT OF THE EVENT RESULTING IN PROLONGATION OF THE PROCEDURE. ADEQUATE FLUSH HAD BEEN MAINTAINED. THE DEVICES WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). PRE-DEPLOYMENT ELECTRI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401438 ↗
• MalfunctionAug 5, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE 2MM X 4CM GALAXY G3 XSFT HELICAL COIL (GLX120204 / L12529), BUT THE COIL BECAME STRETCHED AND COULD NOT DETACH. THE COIL WAS REPOSITIONED WITH THE MARKERS, BUT IT STILL DID NOT DETACH, A NEW COIL REPLACEMENT WAS USED. THE REPORTED ISSUE RESULTED IN A 10-MINUTE PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862448 ↗