GALAXY G3 GLX122505Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886704077626), received between Dec 14, 2018 and Aug 7, 2026 — classified as 1 death, 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (5 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178268 ↗
• MalfunctionMar 16, 2026Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2026, THE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / 2512585S) WAS STRETCHED WHEN THE PHYSICIAN ¿PULL OUT THE COIL.¿ THE PHYSICIAN FELT STRONG RESISTANCE DURING THE ADVANCEMENT OF THE 4MM X 30MM ENTERPRISE 2 (ENF403012 / 9166995) THROUGH THE INTRODUCER SHEATH. NO REPORT OF ANY NEGATIVE PATIENT IMPACT. TWO PHOTOS WERE INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTOS. ON 09-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS A STENT-ASSISTED COIL EMBOLIZATION. THERE WAS NO EVIDENCE OF BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5MM X 5CM GALAXY G3 XSFT (GLX122505). IT WAS CONFIRMED THAT THERE WERE NO NEGATIVE PATIENT IMPACT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613327 ↗
• MalfunctionOct 15, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 2.5MM X 5CM COIL (GLX122505, 31035656) DID NOT DETACH FROM THE DELIVERY WIRE. THERE WAS NO PATIENT INJURY, HOWEVER THERE WAS A ¿SHORT¿ DELAY. THE USER PULLED OUT THE COIL WITH DELIVERY WIRE AND REPLACED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290332 ↗
• MalfunctionApr 26, 2024Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING A PERIPHERAL GASTRODUODENAL ARTERY TO STOP A BLEED, AFTER THE GUIDING CATHETER, DIAGNOSTIC CATHETER, AND MICROCATHETER WERE ADVANCED TO THE TARGET LESION, A CERENOVUS COIL WAS IMPLANTED. THE COMPLAINT COIL, A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / 30901821) WAS TO BE IMPLANTED AS THE SECOND COIL; THE COIL WAS USED AS USUAL, AND ¿SUDDENLY LOST OF RESPONSE AT HAND DURING EMBOLIZATION MANEUVER AT THE TARGET LESION. FLUOROSCOPY SCREEN SHOWED THAT THE PUSH/PULL OF THE DELIVERY WIRE DID NOT CORRESPOND TO THE BEHAVIOR OF THE COIL. WHEN SLOWLY PULLED THE DELIVERY WIRE, THE COIL DID NOT FOLLOW AND WAS EARLY DETACHED IN THE MC. SINCE ABOUT 1CM OF THE COIL REMAINED IN THE MC, FLUSHED WITH NORMAL SALINE AND THE COIL WAS SUCCESSFULLY IMPLANTED.¿ THREE COILS WERE SUBSEQUENTLY IMPLANTED AS CONFIRMED BY ANGIOGRAPHY AND THE PROCEDURE WAS COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 16-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE COIL WAS IMPLANTED. THE COIL DID PREMATURELY DETACH AT THE DETACHMENT ZONE ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194051 ↗
• MalfunctionJun 12, 2023Stretched; Stretched

  AS REPORTED BY THE FIELD, THIS WAS A STENT-ASSISTED COIL EMBOLIZATION WITH PULSERIDER FOR A BASILAR ARTERY ANEURYSM. AFTER DEPLOYMENT OF THE PULSERIDER, A GALAXY G3 XSFT 2.5MM X 5CM (GLX122505, 30404228) WAS USED AS THE 12TH COIL. IT WAS ATTEMPTED TO BE IMPLANTED BY TRANSCELL, BUT IT WAS OVERSIZED AND WAS RETRIEVED, DURING WHICH UNRAVELING OCCURRED. THE ENTIRE SYSTEM WITH MICROCATHETER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED AFTER CONFIRMING UNDER FLUOROSCOPY THAT THERE WAS NO UNRAVELED COIL LEFT IN THE BODY. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE FUBIKI 6FR GUIDING CATHETER, TACTICSPLUS DISTAL ACCESS CATHETER, PHENOME17 MICROCATHETER, CYNCHRO 14 GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106465 ↗
• InjuryFeb 13, 2023Deformation 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 68-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ISCHEMIC STROKE, HEADACHES, CONTROLLED HYPERLIPIDAEMIA, CONTROLLED HYPERTENSION, AND HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED FUSIFORM ANEURYSM ON THE SIDEWALL OF THE LEFT INTERNAL CAROTID ARTERY (ICA), WITH THE PARENT ARTERY LOCATION ON C7 (COMMUNICATING SEGMENT); THE SIZE OF THE TARGET ANEURYSM IS AS FOLLOWS: HEIGHT 12.5MM, DOME 9MM, MAXIMUM ANEURYSM DIAMETER 12.5MM, NECK SIZE 2MM, AND DOME-TO-NECK RATIO (DERIVED) 4.5MM. THE MODIFIED RANKIN SCALE (MRS) SCORE OF 2 ON (B)(6)2021. COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING NINE (9) CERENOVUS COILS WERE DELIVERED VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) AND IMPLANTED: A 7MM X 21CM GALAXY G3 (GLY120721 / 30399454), A 6MM X 15CM GALAXY G3 (GLY120615 / 30409555), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L15756), A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / L16656), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30624678), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30490139), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30624678), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30508852), AND A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L1555

  Patient problems: Aneurysm; Hydrocephalus

  MAUDE report 16369006 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT (B)(6)), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987113 ↗
• MalfunctionDec 5, 2022Fracture; Fracture

  AS REPORTED BY THE FIELD, A GALAXY G3 XSFT 2.5MM X 5CM COIL (GLX122505, 30436889) WAS TAKEN OUT FROM THE POUCH BUT THE COPPER WIRE INSIDE WAS EXPOSED FROM THE DELIVERY SHAFT¿S PROXIMAL SIDE WHERE IS APPROXIMATE 20 CM FROM THE CONNECTOR. THE COMPLAINT COIL WAS NOT USED IN THE PATIENT THEREFORE, THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE AT ANY TIME. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS SECURELY HELD IN PLACE IN THE PACKAGING. THE INNER POUCH WAS SECURELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916487 ↗
• InjuryJun 14, 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

  AS REPORTED BY THE STERLING STUDY, A 64-YEAR-OLD FEMALE PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF DIABETES, CONTROLLED HYPERTENSION, BEING A PREVIOUS SMOKER, DEPRESSION, HEPATITIS C, AND CHRONIC BACK PAIN, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) SACCULAR ANEURYSM WITH MODIFIED RANKIN SCALE (MRS) SCORE 2 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 11.5MM, DOME 9.8MM, MAXIMUM ANEURYSM DIAMETER 10.8MM, NECK SIZE 7.1MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.5MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ L16383), A GALAXY G3 6MM X 10CM (GLY120610/L13911), A GALAXY G3 6MM X 15CM (GLY120615/K10645), A GALAXY G3 6MM X 20CM (GLY120620/L14866), A GALAXY G3 8MM X 24CM (GLY120824/30530863), GALAXY G3 7MM X 15CM (GLY120715/L15636), GALAXY G3 9MM X 25CM (GLY120925/L13514), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/304943930, A GALAXY G3 XSFT 3MM X 4CM (GLX120304/30370440), AND A 2.5MM X 4MM GALAXY G3 XTRASOFT (30371932). THREE (3) NON- CERENOVUS COILS WERE USED: TWO TARGET 360 ULTRA AND ONE TARGET 360 NANO (ALL STRYKER). A NEUROFORM ATLAS

  Patient problems: Aneurysm

  MAUDE report 14687350 ↗
• MalfunctionMay 10, 2022Material Rupture; Positioning Problem; Material Rupture; Positioning Problem

  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 14345515 ↗
• InjuryApr 11, 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 CORONARY ARTERY DISEASE (CAD)U, DEEP VEIN THROMBOSIS (DVT) / PULMONARY EMBOLISM (PE), CONTROLLED HYPERTENSION, SMOKING (PREVIOUS), ACUTE KIDNEY FAILURE, INTRACRANIAL ANEURYSMS (TOTAL OF 3 INCLUDING TARGET), CLASS 3 OBESITY (BMI 41 KG/M2), AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM WITH HUNT & HESS GRADE 2 ON (B)(6) 2020. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 4.4MM, DOME 4.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.7MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.1MM. COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING SIX (6) CERENOVUS SPECTRA COILS: A 3.5MM X 6.6CM MICRUSFRAME 10 (MFR100356 / L12781), A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L14864), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L15547), A 1.00MM X 1.50CM GALAXY G3 MINI (GLM910015 / L13801), A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30379812), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L13691), AND ONE (1) COMPETITOR COIL, A 1.5MM X 2CM TARGET HELICAL NANO COIL (STRYKE

  Patient problems: Aneurysm

  MAUDE report 14079452 ↗
• MalfunctionApr 5, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) COIL EMBOLIZATION PROCEDURE, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A 4FR SHEATH. AN ANGIO CATHETER WAS ADVANCED TOWARD THE RIGHT INTERNAL THORACIC ARTERY (RITA). FROM THERE, A MICROCATHETER (UNSPECIFIED BRAND) WAS ADVANCED TO THE SHUNT, AND EMBOLIZATION WAS INITIATED. A FEW GALAXY G3 XSFT COILS WERE IMPLANTED AND ONE OF THE COMPLAINT PRODUCTS, A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / 30550293) WAS INSERTED INTO THE MICROCATHETER FOR ADDITIONAL IMPLANTATION. HOWEVER, IT WAS UNABLE TO BE INTRODUCED INTO THE HUB OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO HAVE THE COIL COME OUT FROM THE DISTAL END OF THE INTRODUCER IN THE AIR, BUT THE SAME ISSUE CONTINUED. IT WAS REPLACED WITH ANOTHER 2.5MM X 5CM GALAXY G3 XSFT (GLX122505) AND THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. VIA ADDITIONAL INFORMATION, NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSHED AND THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE DEVICE ADVANCEMENT, BUT THE TIP OF THE INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018024 ↗
• MalfunctionFeb 2, 2022Material Rupture; Positioning Problem; Material Rupture; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION PROCEDURE FOR MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCA), AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A SHEATH (4FR). AN ANGIO CATHETER WAS ADVANCED TO THE LEFT INTERNAL THORACIC ARTERY (LITA). FROM THERE, A CONCOMITANT MICROCATHETER WAS ADVANCED TOWARD A SHUNT. AFTER IMPLANTING SEVERAL COMPETITIVE COILS, A GALAXY G3 XSFT 2.5MM X 5CM COIL (GLX122505, 30558377) WAS OPENED FOR ADDITIONAL EMBOLIZATION AND INSERTED INTO THE MICROCATHETER. THE PHYSICIAN TOOK OUT THE COIL AND ROLLED IT, BUT IT WAS NOT ABLE TO MAKE A SHAPE AS THE PHYSICIAN INTENDED, AND IT WAS DECIDED TO RE-SHEATH IT ONCE. AT THAT TIME, THE USER TRIED TO RE-SHEATH, BUT EVEN THOUGH THE RE-SHEATH TOOL WAS SLIDING, THE INTRODUCER SHEATH DID NOT RETURN TO ITS ORIGINAL SHAPE, AND THE WIRE WAS EXPOSED MIDWAY. THEREFORE, THE PHYSICIAN STOPPED USING IT AND REMOVED THE ENTIRE DELIVERY SYSTEM FROM THE PATIENT¿S BODY. THE PHYSICIAN TOOK OUT ANOTHER GALAXY G3 COIL OF THE SAME CATALOG NUMBER, AND ROLLED UP IT, AND THIS ONE WAS ROLLED UP AS THE PHYSICIAN WANTED, SO THE PROCEDURE PROCEEDED. THE LITA WAS IMPLANTED WITH THE GALAXY G3 COILS, AND A DELTAFILL18 3MM X 12CM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423312 ↗
• 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 ((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 13010228 ↗
• 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 12302331 ↗
• InjuryJul 21, 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 UNCONTROLLED HYPERTENSION AND ACTIVE SMOKING UNDERWENT COIL EMBOLIZATION OF A RUPTURED WIDE-NECKED LEFT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 3) ON (B)(6) 2019. AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6) 2020, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. ON (B)(6) 2020, THE PATIENT SUBSEQUENTLY UNDERWENT A BALLOON-ASSISTED COIL EMBOLIZATION DUE TO INCREASE IN ANEURYSM SIZE. A TOTAL OF 19 COMPETITOR COILS WERE IMPLANTED WITH MODIFIED RAYMOND-ROY SCORE OF CLASS IIIB. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. ON (B)(6) 2019, IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED POSTERIOR CIRCULATION ANEURYSM ON THE LEFT SIDE WALL OF THE PCA WITH THE FOLLOWING DIMENSIONS: HEIGHT 8.7MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 11.1MM, NECK SIZE 6.0MM, AND DOME-TO-NECK RATIO 1.9MM.

  Patient problems: Aneurysm

  MAUDE report 12207744 ↗
• InjuryMar 16, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / 30393957) WAS SELECTED AS THE FIRST COIL USED, BUT THE COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO RESHEATH AND RETRACT THE COIL BUT IT UNEXPECTEDLY DETACHED AT THE DETACHMENT ZONE. THE COIL LOOP SUBSEQUENTLY PROTRUDED OUT OF THE ANEURYSM INTO THE PARENT ARTERY. THE COMPLAINT COIL WAS SAFELY REMOVED FROM THE PATIENT USING A SNARE. IT WAS REPLACED AND THE PROCEDURE WAS RESUMED TO COMPLETION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495935 ↗
• InjuryAug 11, 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) FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES, MIGRAINES, AND ANXIETY PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) ON (B)(6) 2019 AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) BIFURCATION ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RUPTURED MIDLINE ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.7MM, DOME 8.1MM, MAXIMUM ANEURYSM DIAMETER 8.1MM, NECK SIZE 2.8MM, AND DOME-TO-NECK RATIO 2.9MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/UNKNOWN LOT #), ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/ L13333), ONE 2MM X 2CM GALAXY G3 XSFT (GLX120202/L13330), ONE 2.5MM X 4.5CM GALAXY G3 MINI (GLM925045/S15174), ONE 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/L15425), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L14685), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L15571), TWO 1MM X 2CM GALAXY G3 MINI (GLM910020/L14855), TWO 1MM X 2.5CM GALAXY G3 MINI (GLM910025/L13971), ONE 1MM X 1.5CM GALA

  Patient problems: Stroke/CVA

  MAUDE report 10391230 ↗
• MalfunctionJul 28, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, THE DELIVERY SYSTEM OF A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505, L15293) AND A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535, L13110) IS CAUSING SOME CONCERNS, THE COILS DO NOT FILL THE ANEURYSM AS WELL AS THE USER WAS HOPING. IT IS DIFFICULT TO POSITION THEM; THEY ARE EITHER PROTRUDING INTO A VESSEL OR THEY ARE DIFFICULT TO BE FULLY ADVANCED. THE USER REPORTED THAT SOMETIMES THEY CANNOT ADVANCE A COIL FULLY AND IT¿S NOT DUE TO SIZING, PERHAPS IT IS INDEED DUE TO THE DELIVERY SYSTEM. THE CATHETER KICK BACK IS VERY CONCERNING. THE SYSTEM, ESPECIALLY THE DELIVERY WIRE FEELS VERY STIFF. IT¿S REQUIRING SOME MANIPULATION. DEPLOYMENT OF COILS TAKES TOO LONG, AS THEY ARE NOT EASY TO HANDLE, WHICH PRESENTS A RISK OF CLOT FORMING. THERE WAS NO PATIENT INJURY REPORTED. IMAGING WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332250 ↗
• MalfunctionJul 21, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE A SUBARACHNOID HEMORRHAGE (SAH) COIL EMBOLIZATION PROCEDURE, THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L13187) WAS USED PER THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS RESISTANCE FELT BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE DELIVERY WIRE TO CONFIRM THE SITUATION. THE COMPLAINT COIL APPEARED TO HAVE UNRAVELED AND WAS NO LONGER USABLE. THE MICROCATHETER WAS FLUSHED AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10303441 ↗
• DeathJul 1, 2020Migration; Migration

  AS REPORTED BY THE (B)(4) STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF SMOKING, CONTROLLED HYPERLIPIDEMIA, CONTROLLED HYPERTENSION, AND INTRACRANIAL ANEURYSM (SMALL RIGHT ANTERIOR TEMPORAL ARTERY) PRESENTED WITH AN UNRUPTURED ANTERIOR CIRCULATION ANEURYSM ON RIGHT SIDEWALL OF THE ANTERIOR COMMUNICATING ARTERY ON (B)(6) 2020. THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 5.0MM, DOME 4.3MM, MAXIMUM ANEURYSM DIAMETER 6.8MM, NECK SIZE 3.6MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. NEUROFORM ATLAS STENT-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2020 WITH THE IMPLANTATION OF ONE 3MM X 4CM GALAXY G3 XSFT (GLX120304/L16485) AND ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/L13317) VIA AN EXCELSIOR SL-10 MICROCATHETER. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. PER THE CASE REPORT FORM (CRF), ONE 2MM X 2CM GALAXY G3 XSFT (GLX120202/L12961) COIL WAS USED BUT NOT IMPLANTED. HEPARIN AND PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. THERE WAS NO INTRAOPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT REPORTED. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CON

  Patient problems: Death; Hemorrhage, Subarachnoid

  MAUDE report 10218909 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) 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 5

  Patient problems: Rupture; Thromboembolism

  MAUDE report 9751437 ↗
• MalfunctionFeb 6, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MPCA) COIL EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE BETWEEN A MICROCATHETER (PROWLER SELECT PLUS, LPES) AND A 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505, L13785). IT WAS NOT ABLE TO COME OUT FROM THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THIS WAS THE FIRST COIL BEING USED. THE LESION WAS THE COLLATERAL CIRCULATION COMING FROM THE RIGHT INTERNAL MAMMARY ARTERY. THE SAME PROWLER SELECT PLUS MC WAS USED SUCCESSFULLY WITH THE REPLACED COIL. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676008 ↗
• MalfunctionDec 23, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION AT THE GASTRODUODENAL ARTERY PERIPHERY DUE TO INTRA-ABDOMINAL HEMORRHAGE, THE PARENT VESSEL OCCLUSION WAS PERFORMED ON A SPINDLE-SHAPED ANEURYSM, THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L13094) WAS CONNECTED TO THE ENPOWER CONTROL CABLE (ECB00018200 / L16431), WHICH HAD BEEN USED TO FILL THE ANEURYSM, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AND THE COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE WAS THEN REPLACED BUT THE SAME ISSUE OCCURRED; THE SYSTEM READY LIGHT DID NOT ILLUMINATE. THE COIL WAS REPLACED WITH A 3MM X 6CM GALAXY G3 XSFT COIL, THE POWER SUPPLY WAS CONFIRMED, AND THE COIL DETACHED. THE PROCEDURE WAS COMPLETED; THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511395 ↗
• MalfunctionDec 3, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MAPC COIL EMBOLIZATION PROCEDURE, 2.5MM X 5CM GALAXY G3 XSFT (GLX122505, L15161) WAS REROLLED SEVERAL TIMES. HOWEVER, IT UNRAVELED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE LESION WAS THE COLLATERAL CIRCULATION COMING FROM THE RIGHT INTERNAL MAMMARY ARTERY. THE BLOOD VESSELS WAS THIN. ADEQUATE FLUSH WAS NOT MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. A MICROCATHETER (LEONIS, MOVA) AND AN ENPOWER CONTROL CABLE WERE USED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402582 ↗