GALAXY G3 GLX123575Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704077664), received between Mar 1, 2018 and May 1, 2025 — classified as 8 injuries, 11 malfunctions.

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

• InjuryMay 1, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HOSOMOTO K, KURIYAMA M, HIROTSUNE N, TERASAKA K. ENDOVASCULAR COILING FOR A RUPTURED MIDDLE CEREBRAL ARTERY-LENTICULOSTRIATE ARTERY BIFURCATION ANEURYSM SUSPECTED TO BE A PSEUDOANEURYSM: A CASE REPORT. NMC CASE REP J. 2024 OCT 11;11:267-272. DOI: 10.2176/JNS-NMC.2024-0102. PMID: 39479471; PMCID: PMC11524614. OBJECTIVE AND METHODS: THIS ARTICLE PRESENTED TO REPORT A SUCCESSFUL USED OF COIL EMBOLIZATION TO TREAT A RUPTURED ANEURYSM THAT WAS CONSIDERED TO BE A PSEUDOANEURYSM LOCATED AT THE MCA-LSA BIFURCATION. A 43-YEAR-OLD WOMAN WAS TREATED WITH CARDIOPULMONARY ARREST DUE TO A SUBARACHNOID HEMORRHAGE. A RIGHT MIDDLE CEREBRAL ARTERY-LENTICULOSTRIATE ARTERY BIFURCATION ANEURYSM WAS DETECTED, WHICH WAS SUSPECTED TO BE A PSEUDOANEURYSM. THE ANEURYSMAL SHAPE CHANGED DYNAMICALLY, PROBABLY BECAUSE OF THROMBUS FORMATION AND RESOLUTION. DELAYED CEREBRAL VASOSPASM WAS ALSO OBSERVED. A SIMPLE COIL EMBOLIZATION USING THREE DETACHABLE COILS SUCH (1) 3.5 MM × 7.5 CM GALAXY G3 XSFT (CERENOVUS, IRVINE, CA, USA), (2) 2MM × 3 CM TARGET NANO (STRYKER), AND (3) 1.5 MM × 2 CM TARGET NANO WAS PERFORMED. CLOSE FOLL

  Patient problems: Aneurysm

  MAUDE report 21942993 ↗
• MalfunctionFeb 26, 2025Stretched; Stretched

  IT WAS REPORTED THAT THE GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ 30820685) COIL WAS STRETCHED DURING RE-SHEATHING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469767 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (B)(6), A 49-YEAR-OLD MALE (B)(6) WITH NO RELEVANT MEDICAL HISTORY, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WITH A MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2023. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.8MM, DOME 7MM, MAXIMUM ANEURYSM DIAMETER 8.2MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH EIGHT (8) CERENOVUS COILS: A GALAXY G3 6MM X 15CM (GLY120615/30715066), A GALAXY G3 XSFT 2.5MM X 3.5CM (GLX122535/30563820), A GALAXY G3 MINI 2MM X 3CM (GLM920030/30878377), A GALAXY G3 XSFT 4MM X 8CM (GLX120408/30901816), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/30719529), A GALAXY G3 XSFT 3.5MM X 9CM (GLX123509/30571102), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/30526863), AND A GALAXY G3 MINI 2MM X 4CM (GLM920040/30830570) VIA AN EXCELSIOR SL-10 (STRYKER) 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. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED IN THE CRF. IMMEDIATE PO

  Patient problems: Aneurysm

  MAUDE report 19448118 ↗
• MalfunctionApr 26, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER DEPLOYING THE COMPLAINT COIL, A 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / 30563821) IN THE ANEURYSM, THE COIL COULD NOT BE DETACHED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194163 ↗
• MalfunctionJan 25, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  ON (B)(6) 2024, THE HEALTHCARE PROFESSIONAL INITIATED THE COMPLAINT WITH LIMITED DETAILS. IT WAS REPORTED THAT ¿THE PROCEDURE DETAILS WERE UNKNOWN. THE GALAXY G3 XSFT COILS WERE USED AND RESISTANCE WAS FELT IN THE MICROCATHETER. CONTINUOUS FLUSH WAS DONE. THE LESION WAS UNKNOWN. OTHER CONCOMITANT DEVICE WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE GALAXY G3 XSFT COILS WERE USED IN ACCORDANCE WITH THE IFU. AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS PLACED IN THE ANEURYSM. THE FIRST FRAMING GALAXY G3 COIL WAS INTRODUCED WITHOUT ISSUE, WAS DETACHED, AND IMPLANTED. THEN THE SECOND COIL, A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30666663) ENCOUNTERED RESISTANCE AND GOT STUCK INSIDE THE MICROCATHETER (NOT AT THE PROXIMAL SIDE, PROBABLY IN THE MIDDLE PART OF THE MICROCATHETER). THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL AND THE COIL BECAME UNRAVELED. THE MICROCATHETER WAS REPLACED WITH ANOTHER EXCELSIOR® SL-10® MICROCATHETER AND THE COIL WAS REPLACED WITH THE THIRD C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585278 ↗
• 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 17281255 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACTIVE SMOKING, 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) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5MM, DOME 2MM, MAXIMUM ANEURYSM DIAMETER 5MM, NECK SIZE 3MM, AND DOME-TO-NECK RATIO OF 0.7MM. THE PARENT VESSEL DIAMETER WAS 3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH A 3.5MM X 7.5CM GALAXY G3 XTRASOFT (GLX123575/30371940) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COIL WAS SUCCESSFULLY IMPLANTED AT THE TARGET SITE. PACKING DENSITY WAS NOT PROVIDED. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS II. THE PATIENT EXPERIENCED AN INTRAPROCEDURAL ANEURYSM RUPTURE. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, POSSIBLY RELATED TO THE STUDY DEVICE. PATIENT OUTCOME HAS BEEN RECORDED IN THE CRF AS RECOVERED/RESOLVED ON 20-NOV-2022. THERE

  Patient problems: Ruptured Aneurysm

  MAUDE report 16417752 ↗
• MalfunctionJan 4, 2023Entrapment of Device; Deformation Due to Compressive Stress; Migration; Entrapment of Device; Deformation Due to Compressive Stress; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 47-YEAR-OLD FEMALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A 3.5MM BASILAR ARTERY (BA) ANEURYSM, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3074237323) WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER AND PLACED AT THE IDEAL POSITION ON THE FIRST ATTEMPT. AFTER THAT, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE LESION. THE MICROCATHETER WAS SET EXACTLY AT THE MIDDLE OF FOUR MARKERS ON THE PULSERIDER LEAFLET. TWO COIL EMBOLIZATION VIA THE TRANSCELL TECHNIQUE WERE PERFORMED WITHOUT ANY ISSUES. A 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / LOT# UNKNOWN) AND A 2.5MM X 5CM GALAXY G3 (GLY122505 / LOT# UNKNOWN) WERE IMPLANTED. WHEN THE THIRD COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / LOT# UNKNOWN) WAS INSERTED, IT WAS REPORTED THAT THE COIL PENETRATED THE RIGHT UPPER PART OF THE ANEURYSM WHICH RESULTED IN BLEEDING. THIS THIRD COIL WAS DESCRIED AS ¿WOUND OUTSIDE THE ANEURYSM AS IT WAS, AND THE COIL WAS LEFT FOR A WHILE.¿ ANGIOGRAPHY WAS TAKEN AGAIN AFTER A WHILE AND IT WAS CONFIRMED THAT THE BLEEDING HAD STOPPED. AFTER THAT, IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097056 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 62-YEAR-OLD FEMALE PATIENT (SUBJECT (B)(6) UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANTERIOR CIRCULATION ANEURYSM ON (B)(6) 2021. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 6.5MM, DOME 4.2MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 2.9MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 5MM X 15CM (GLY120515 / L13767), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575 /K10486), A GALAXY G3 XSFT 3MM X 6M (GLX120306 /30399443), A GALAXY G3 MINI 2MM X 6CM (GLM920060 /30366491), A GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /L14642), GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /30393176), GALAXY G3 MIMI 1MM X 3CM (GLM910030 /30422323), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /K10600), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /30390764) AND A 1MM X 1.5CM GALAXY G3 MIMI (GLM910015, 30390761) WERE IMPLANTED. A LVIS STENT (MICROVENTION) WAS ALSO IMPLANTED, AND A BALLOON CATHETER (UNKNOWN CATALOG/MANUFACTURER) WAS ALSO USE

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714089 ↗
• MalfunctionOct 24, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN EMERGENT COIL EMBOLIZATION OF AN ANEURYSM, A GALAXY G3 XSFT 3.5MM X 7.5CM COIL (GLX123575, 30675488) WAS PREPPED AND INSERTED INTO A MICROCATHETER (EXSELSIOR SL10). HOWEVER, THERE WAS AN INTENSIVE RESISTANCE FELT IN THE MICROCATHETER (MC). THE COMPLAINT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE MICROCATHETER WAS INSERTED INTO THE ANEURYSM AGAIN AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE UNKNOWN. BASED ON THE VISUAL ANALYSIS OF THE PRE-SHIPMENT PICTURES RECEIVED, THE COIL IS PARTIALLY OUTSIDE THE INTRODUCER; IT CAN BE NOTED WITH A SEVERELY STRETCHED CONDITION AND TANGLED WITH THE REST OF THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657496 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 68-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE SACCULAR ANEURYSM AT THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5.5MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 8.4MM, NECK SIZE 4.3MM, AND THE DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.8MM. COIL EMBOLIZATION WAS PERFORMED WITH A TOTAL OF TEN (10) COILS. THE FOLLOWING SIX (6) CERENOVUS COILS WERE IMPLANTED: ONE 7MM X 21CM GALAXY G3 (GLY120721 / L15699), ONE 6MM X 15CM GALAXY G3 (GLY120615 / L13589), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L13315), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L13521), ONE 3MM X 6CM GALAXY G3 MINI (GLM930060 / L13936) AND ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / L13672). IN ADDITION, FOUR (4) 2MM X 3CM TARGET® 360 NANO¿ COIL (STRYKER) WERE ALSO IMPLANTED. ALL COILS WERE DELIVERED VIA THE HEADWAY® 17 MICROCATHETER (MICROVENTION). A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED. THERE WAS NO INTRA-OPERATIVE ANEURYSM RUPTURE

  Patient problems: Ischemia Stroke

  MAUDE report 15547486 ↗
• MalfunctionAug 31, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5MM X 7.5CM GALAXY G3 COIL (GLX123575, 30498787) WAS USED AS THE 3RD COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327067 ↗
• MalfunctionAug 4, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN UNSPECIFIED GUIDEWIRE WAS USED FROM A GUIDING CATHETER. AN UNSPECIFIED MICROCATHETER (MC) WAS INSERTED AND DELIVERED TO THE LESION. A 3.5MM X 7.5CM GALAXY G3 COIL (GLX123575, 30742427) WAS DELIVERED TO THE LESION VIA THE MICROCATHETER. WHEN DETACHING WAS ATTEMPTED AFTER COILING, THE COMPLAINT COIL WAS EARLY DETACHED IN THE ANEURYSM. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (DIFFERENT CATALOG NUMBER) AND EMBOLIZATION 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 15166904 ↗
• MalfunctionJun 15, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM (5MM) AT THE ANTERIOR COMMUNICATING ARTERY (A-COM), A 3.5MM X 7.5CM GALAXY G3 COIL (GLX123575, K10383) WAS USED AFTER LEADING A CONCOMITANT MICROCATHETER (EXSELSIOR SL10) TO THE TARGET LESION. AFTER A TARGET 360 SOFT COIL (5MM X 15CM) WAS EMBOLIZED TO THE TARGET LESION, THE GALAXY G3 COIL WAS USED AS THE SECOND COIL. WHEN THE COIL WAS ¿PULLED¿ AND THE PHYSICIAN OPERATED THE MICROCATHETER, THE COIL WAS NOT ABLE BE PULLED OUT IN THE MIDDLE. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY WITH THE MICROCATHETER TOGETHER. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697738 ↗
• 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 14687329 ↗
• MalfunctionMar 3, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR THE AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (A-COM), A 3.5MM X 7.5CM GALAXY G3 COIL (GLX123575, L15716) WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS COMPLETELY MADE A SHAPE AS THE PHYSICIAN INTENDED; THE DETACHMENT ATTEMPTED TO BE STARTED. THE DETACHMENT BUTTON WAS PRESSED, AND THERE WAS A DETACHMENT SOUND, THEREFORE THE WIRE WAS PULLED BACK. THE DETACHMENT MARKER STARTED TO MOVE, BUT THE COIL RETURNED A LITTLE AWAY FROM THE TIP OF THE WIRE. THE PROXIMAL END OF THE RADIOPAQUE MARKER OF THE DELIVERY WIRE WAS ALIGNED AT JUST BEYOND THE DISTAL TIP OF THE MICROCATHETER¿S PROXIMAL MARKER, AND THE DETACH BUTTON WAS PRESSED ONCE AGAIN. HOWEVER, THE MICROCOIL STILL GOT PULLED TOGETHER WITH THE DELIVERY WIRE (MOVED ALONG WITH THE MOVEMENT OF THE DELIVERY WIRE). WHEN THE CONTROL BOX WAS TURNED ON AND OFF, THE DETACHMENT BUTTON WAS PRESSED ABOUT FOUR TIMES, AND THE WIRE WAS PULLED BACK, THE DETACHMENT FINALLY MANAGED. AFTER THAT, THE COIL EMBOLIZATION WAS COMPLETED WITHOUT ANY PROBLEM AND THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE. CONCOMITANT DEVICE WAS A MICROCATHETER (PHENOM, MEDTORNIC)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660017 ↗
• 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 12302361 ↗
• MalfunctionDec 3, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE SHEATH INTRODUCER ON THE 3.5MM X 7.5CM GALAXY G3 XSFT COIL (GLX123575 / L15634) BECAME DAMAGED DURING THE ATTEMPT TO RESHEATH THE COIL TO FIT THE SIZE. THE COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE 3.5MM X 7.5CM GALAXY G3 XSFT COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 12/2/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404460 ↗
• MalfunctionMar 1, 2018Stretched; Material Integrity Problem; Stretched; Material Integrity Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM, THE DELIVERY HYPOTUBE OF THE 4 MM X 10 CM GALAXY G3 XSFT (GLX120410/L10274) THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (DCS) KINKED DURING ADVANCEMENT AND COULD NOT BE INSERTED ANY FURTHER. RESISTANCE WAS ENCOUNTERED AT THE ROTATING HEMOSTATIC VALVE (RHV). THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO LOSS OF CEREBRAL TARGET POSITION AS A RESULT OF THIS ISSUE. AN ADEQUATE CONTINUOUS FLUS WAS MAINTAINED THROUGH THE HEADWAY DUO (MICROVENTION) MICROCATHETER. PRIOR TO THIS COIL, ONE MICROVENTION COIL WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO APPARENT KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL DAMAGE WAS NOTED TO THE COIL FOLLOWING THE EVENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO VISIBLE PRODUCT DAMAGE WAS OBSERVED PRIOR TO USE. THE 3.5 MM X 7.5 CM GALAXY G3 XSFT (GLX123575/L10401) THERMO-MECHANICAL COIL WAS SELECTED FOR USE AND INSERTED; HOWEVER, THE PHYSICIAN WAS NOT PLEASED WITH THE POSITION OF THE COIL AND THE COIL WAS NOT PLACED IN THE TARGET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307433 ↗