GALAXY G3 GLX120304Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886704077688), received between Aug 17, 2018 and Dec 9, 2025 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 3MM X 4CM COIL (PRODUCT CODE: GLX120304, LOT NUMBER UNKNOWN) AND A GALAXY G3 MINI 2.5MM X 3.5CM COIL (PRODUCT CODE: GLM925035, LOT NUMBER UNKNOWN) KINKED INSIDE A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER UNKNOWN), WITH A NOTE THAT THE LUMEN WAS NOT COMPATIBLE. THE PRODUCTS INDICATED THAT BOTH COILS WERE KINKED OR BENT IN THE PATIENT AND IMPEDED, WHILE THE MICROCATHETER WAS OBSTRUCTED IN THE PATIENT WITHOUT LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR CONSEQUENCES, AND NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGES IN THE PATIENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758095 ↗
• MalfunctionMay 28, 2025Stretched; Difficult to Advance; Stretched; Difficult to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, AFTER THE USER APPROACHED THE TARGET LESION WITH USING MARVEL MICROCATHETER, THE GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304, 30975598) WAS INSERTED INTO THE MICROCATHETER (MC). THE GALAXY G3 XSFT GOT STUCK AND UNRAVELED DURING USE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-MAY-2025 CONFIRMED THAT THE COIL WAS UNRAVELED INSIDE THE MICROCATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096897 ↗
• InjuryNov 12, 2024Migration; Migration

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A GALAXY G3 XSFT 3MM X 4CM (GLX120304/ LOT # UNKNOWN) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. THE PROCEDURE WAS COMPLETED, AND NO OBVIOUS COMPLICATIONS WERE CONFIRMED. HOWEVER, 14 DAYS AFTER THE PROCEDURE, COIL MIGRATION WAS OBSERVED. THE EVENT REQUIRED THE SURGICAL INTERVENTION OF A CRANIOTOMY TO REMOVE THE MIGRATED COIL. TWELVE DAYS AFTER THE CRANIOTOMY, THE PATIENT WAS DISCHARGED FROM HOSPITAL WITH THE SYMPTOM OF TRANSIENT OCULOMOTOR NERVE PALSY (SYMPTOMS INCLUDE DOUBLE VISION, DROOPING EYELID, AND A PUPIL THAT MAY BE DILATED). BY 15-MONTHS POST PROCEDURE, NO RECURRENCE OF THE ANEURYSM WAS OBSERVED, AND IMPROVEMENT OF THE OCULOMOTOR NERVE PALSY WAS CONFIRMED. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A COIL EMBOLIZATION OF RUPTURED ANEURYSM BETWEEN RIGHT INTERNAL CAROTID ARTERY AND POSTERIOR COMMUNICATING ARTERY TO TREAT SUBARACHNOID HEMORRHAGE. THE PROCEDURE DATE WAS UNKNOWN. A 7 FR SHEATH AND A 7 FR ROAD-MASTER 90 GUIDING CATHETER (GOODMAN) WERE PLACED INTO THE RIGHT ICA. TWO EXCELSIOR SL10 MICROCATHETERS (STRIKER) WERE INSERTED INTO THE ANEURYSM. FRAMING WAS PERFORMED USING A TARGET XL 360 SOFT 6 MM X 20

  Patient problems: Visual Disturbances

  MAUDE report 20662645 ↗
• MalfunctionSep 17, 2024Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY, AFTER AN EXSELSIOR SL10 MICROCATHETER (MC) WAS APPROACHED, A GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304, 30663166) WAS INSERTED. THERE WAS A RESISTANCE INSIDE THE MICROCATHETER AND THE GALAXY G3 COIL WAS RE-SHEATHED FOR SIZE CHANGE. AFTER ANOTHER COIL WAS PLACED, THE GALAXY G3 COIL (30663166) WAS INSERTED AGAIN, BUT THE WIRE COULD NOT BE ADVANCED AND THE GALAXY G3 COIL WAS EVEN NOT ABLE TO BE RE-SHEATHED. BOTH THE GALAXY G3 COIL AND THE MICROCATHETER WERE PULLED FROM THE PATIENT¿S BODY TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER COIL. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237201 ↗
• MalfunctionAug 7, 2023Stretched; Stretched

  AS REPORTED BY THE FIELD, A GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304, 30797246) BECAME STRETCHED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469628 ↗
• 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 15-DEC-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 16704326 ↗
• 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 / L155

  Patient problems: Aneurysm; Hydrocephalus

  MAUDE report 16368997 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (B)(4), A 46-YEAR-OLD FEMALE PATIENT (B)(6) WITH A HISTORY OF HYPERTENSION (CONTROLLED), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) SIDE WALL 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 4.5MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 3.3MM, NECK SIZE 2.1MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: A 3.5MM X 6CM MICRUSFRAME S (L16863), A GALAXY G3 XTRASOFT 3MM X 4CM (GLX120304/L16554), A 2MM X 3CM GALAXY G3 MINI (GLM920030/L30546463), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30546460), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30393176), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/ 30490127) AND A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/30390770) VIA AN EXCELSIOR SL-10 0165 45 TIP 150 CM MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE

  Patient problems: Aneurysm

  MAUDE report 16194855 ↗
• MalfunctionNov 7, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304, 30757476) WAS USED AS A FIRST COIL. HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED BRAND 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 15743897 ↗
• 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 14687492 ↗
• InjuryMar 4, 2022Migration; Migration

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: DING D, LIU KC. MANAGEMENT STRATEGIES FOR INTRAPROCEDURAL COIL MIGRATION DURING ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS. J NEUROINTERV SURG. 2014 JUL;6(6):428-31. DOI: 10.1136/NEURINTSURG-2013-010872. EPUB 2013 AUG 6. PMID: 23921713. OBJECTIVE AND METHODS: THIS ARTICLE PRESENTS A PARTICULAR MANAGEMENT STRATEGY FOR CORRECTION OF A DISTAL COIL MIGRATION IN A PATIENT UNDERGOING ENDOVASCULAR COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3MM X 4CM GALAXY G3 XSFT COIL & PROWLER 10 MICROCATHETER. CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: GALAXY G3 XSFT COILS; GALAXY G3 MINI COILS. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 6F CHAPERON GUIDING CATHETER (MICROVENTION); 0.014" TRANSEND MICROWIRE (BOSTON SCIENTIFIC); 3/30 MM ATLAS 2 STENT (STRYKER) . ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A (B)(6) MALE PATIENT UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. A PROW

  Patient problems: Thromboembolism

  MAUDE report 13667932 ↗
• MalfunctionDec 3, 2021Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION OF A RUPTURED OPHTHALMIC-INTERNAL CAROTID ARTERY ANEURYSM OF APPROXIMATELY 1.5MM X 4MM IN SIZE, THE 3MM X 4CM GALAXY G3 XSFT COIL (GLX120304 / L16436) WAS USED AS THE FIRST FRAMING COIL. HOWEVER, THERE WAS AN INTENSE RESISTANCE FELT FROM THE MIDDLE TO THE END OF THE COIL IMPLANTATION. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. IT WAS IMPOSSIBLE TO WIND THE LAST 1CM OF THE COMPLAINT COIL. THE PHYSICIAN RE-SHEATHED THE COMPLAINT COIL BUT THE COIL DETACHED INSIDE THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). AS A RESULT, THE COIL AND MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT. THE COIL WAS THEN REMOVED FROM THE MICROCATHETER. THE SAME CONCOMITANT MICROCATHETER WAS USED WITH COMPETITOR COILS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PHOTOS OF THE COMPLAINT DEVICE WERE INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925524 ↗
• 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 12368683 ↗
• MalfunctionAug 2, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN EMERGENT AN PROCEDURE, A 3MM X 4CM GALAXY G3 XSFT COIL WAS USED AFTER AN UNSPECIFIED CONCOMITANT MICROCATHETER (MC) WAS USED. HOWEVER, THERE WAS RESISTANCE FELT DURING ADVANCEMENT OF THE COIL AND THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259300 ↗
• MalfunctionJul 30, 2021Break; Separation Failure; Break; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE PHYSICIAN PREPPED THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). IT WAS CONFIRMED THAT THE CONNECTING CABLE WAS ENERGIZED. IT WAS REPORTED THAT THE 3MM X 4CM GALAXY G3 XSFT COIL (GLX120304 / L16036) FAILED TO DETACH. IT WAS REPLACED WITH ANOTHER COIL AND THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. ON 19 JULY 2021, ADDITIONAL INFORMATION WAS RECEIVED, THE INFORMATION INDICATED THAT THE INTRODUCER SHEATH OF THE 3MM X 4CM GALAXY G3 XSFT COIL WAS ALSO DAMAGED. DURING THE SAME PROCEDURE, A 1.00MM X 2.00CM GALAXY G3 MINI COIL (GLM910020 / 30513162) WAS USED AS A FINISHING COIL, BUT THIS COIL ALSO FAILED TO DETACH. IT WAS REMOVED FROM THE COIL MASS AND THE PROCEDURE WAS REPORTED AS COMPLETED WITHOUT ISSUES. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J (B)(4)AFFILIATES AND INCLUDED IN THE COMPLAINT FILE ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256946 ↗
• 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 12207738 ↗
• MalfunctionApr 23, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC PORTAL EMBOLIZATION (PTPE) PROCEDURE, THE 3MM X 4CM GALAXY G3 XSFT COIL (GLX120304 / L13444) WAS USED, BUT IT GOT STUCK ON THE CONCOMITANT MICROCATHETER DURING INSERTION THROUGH THE MICROCATHETER BEFORE THE COIL COULD EXIT THE MICROCATHETER. AS A RESULT, THE COIL WAS NOT ABLE TO BE ADVANCED. CONTINUOUS FLUSH HAD NOT BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS RESISTANCE WAS REPORTED TO BE FELT WHEN THE COIL WAS INSIDE THE MICROCATHETER. THE COIL WAS PUSHED BACK AND FORTH BUT IT BECAME UNRAVELED INSIDE THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED UNDETACHED FROM THE PATIENT AND REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THERE WAS NO BLOOD FLOW RESTRICTION OR REDUCTION DUE TO THE REPORTED EVENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716696 ↗
• InjuryDec 3, 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 894-026) 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 10942544 ↗
• 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 4

  Patient problems: Aneurysm

  MAUDE report 10936351 ↗
• MalfunctionJun 8, 2020Mechanical Problem; Stretched; Mechanical Problem; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3MM X 4CM GALAXY G3 XSFT COIL (GLX120304, L14009) WAS ATTEMPTED TO BE RE-SHEATHED TO CHANGE THE SIZE. HOWEVER, THE SHEATH INTRODUCER GOT SPLIT AND IT WAS NOT ABLE TO BE RE-SHEATHED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED AND MECHANICALLY DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127994 ↗
• MalfunctionMar 31, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC), THE 3MM X 4CM GALAXY G3 XSFT COIL (GLX120304 / L13942) WAS THE FIRST COIL TO BE USED. IT WAS REPORTED THAT THERE WAS RESISTANCE BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) BEFORE THE COIL REACHED THE TARGET LESION. THE WIRE WAS RETRACTED TO REMOVE THE COIL FROM THE MICROCATHETER, BUT THE COIL BECAME UNRAVELED. THE MICROCATHETER WAS ALSO REMOVED AND FLUSHED; IT WAS OBSERVED THAT ONLY THE CLOT CAME OUT. THE MICROCATHETER DID NOT APPEAR TO BE BLOCKED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THE REPORTED ISSUE DID NOT RESULT IN ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9904332 ↗
• MalfunctionDec 2, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION TO THE ARTERIA COMMUNICANS ANTERIOR (A-COM), A 3MM X 4CM GALAXY G3 XSFT COIL (GLX120304, L12389) WAS USED BUT IT WAS NOT ABLE TO BE RE-SHEATHED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER STATED THAT THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395447 ↗
• MalfunctionNov 9, 2018Component Missing; Component Missing

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN OPENED THE PACKAGE TO THE GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304 / L12525), HE NOTICED THAT THE DEVICE HAD A MISSING "FLOURO" SAVER MARKER. THERE WERE SUPPOSED TO BE FIVE (5) FLUORO SAVER MARKERS ON THE DEVICE, BUT ON THIS GALAXY G3 XSFT 3MM X 4CM COIL, THERE WERE ONLY 4 MARKERS. THE ISSUE WAS NOTICED BEFORE THE DEVICE WAS INSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN MADE THE DECISION TO USE THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TOTAL OF FIVE (5) SPECTRA COILS IMPLANTED IN THE "PATIENTS". IT WAS CONFIRMED THAT THERE WERE NO ANOMALIES WITH THE OTHER FOUR (4) COILS; THEY ALL HAVE THE COMPLETE NUMBER OF FLUORO SAVER MARKERS ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055759 ↗
• MalfunctionAug 17, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY, THE GALAXY G3 XSFT COIL 3MM X 4CM (GLX120304 / L10820) WAS SELECTED AS THE FIRST COIL USE IN THE PROCEDURE. WHEN THE SLEEVE WAS UNLOCKED TO DELIVER THE COIL INTO THE INTO THE MICROCATHETER, THE TIP OF THE SHEATH HAD A CUT AND AS A RESULT, THE COIL COULD NOT BE DELIVERED. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER DELAY OR ISSUE. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE; THE COIL INTRODUCER WAS NOT TORN AND THERE WAS NO RESISTANCE ENCOUNTERED BETWEEN THE GALAXY G3 COIL AND THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). THE PRODUCT WAS INDICATED AS AVAILABLE TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795587 ↗