GALAXY G3 GLX120408Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886704077732), received between Dec 11, 2017 and Jan 6, 2026 — classified as 10 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Stretched” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 6, 2026Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION, THE PHYSICIAN FILLED THE ANEURYSM WITH A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 2022547S) COIL, AND IT WAS FOUND THAT THE COIL HAD UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT; THE REPLACEMENT COIL WAS DELIVERED WITH THE SAME ORIGINAL CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN). DURING THE DELIVERY OF THE 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (ENCR401612 / 9784479), THE STENT WAS IMPEDED AT THE PROXIMAL END OF THE MICROCATHETER AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED ONLY THE STENT AND DELIVERED IT AGAIN, BUT THE SAME ISSUE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979782 ↗
• MalfunctionDec 17, 2025Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SHEATH OF THE GALAXY G3 XSFT 4MM X 8CM COIL (GLX120408/UNKNOWN LOT#) WAS BROKEN WHILE RE-SHEATHING THE COIL. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS ON THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827900 ↗
• MalfunctionDec 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SHEATH SYSTEM OF THE GALAXY G3 XSFT 4MM X 8CM COIL (PRODUCT CODE: GLX120408, LOT NUMBER UNKNOWN) WAS BROKEN WHEN TRANSFERRING THE COIL WIRE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820776 ↗
• MalfunctionApr 21, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 4MM X 8CM (GLX120408, 30820682) COULDN¿T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND UNSPECIFIED MICROCATHETER AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873268 ↗
• MalfunctionJul 8, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY COIL (GLX120408, LOT 31035653) FAILED TO DETACH. THE ENPOWER CONTROL CABLE (ECB00018200, 30978852) WAS CHANGED TO A NEW ONE, BUT AGAIN DID NOT DETACH. THERE WAS A 15-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUN-2024 INDICATED THAT THE GALAXY COIL WAS INSIDE THE ANEURYSM AND THE USER STARTED TO DETACH IT, HE TOOK THE ENPOWER CONTROL CABLE, CONNECT SYSTEM, BUT SYSTEM READY LIGHT WAS NOT ON, HE CHANGED FOR NEW CABLE (SAME LOT AS PREVIOUS) AND SAME THING SYSTEM READY LIGHT WAS NOT ON AND HE COULDN¿T DETACH THE COIL. THERE WAS NO ALTERNATIVE COIL SO HE NEEDED TO USE COMPETITOR PRODUCT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19694402 ↗
• 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 19447960 ↗
• MalfunctionApr 26, 2024Break; Stretched; Break; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL INTRODUCER SHEATH OF THE 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30778048) BECAME BROKEN DURING RESHEATHING AND THE EMBOLIC COIL COMPONENT WAS STRETCHED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194106 ↗
• 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 18585276 ↗
• InjuryJun 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) SIDE WALL ANEURYSM ON (B)(6) 2022. THE HUNT & HESS GRADE WAS 3, THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE TARGET ANEURYSM WAS AS FOLLOWS: HEIGHT 4.1MM, DOME 5.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS PERFORMED USING THREE (3) CERENOVUS COILS: A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / (B)(6)), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / (B)(6)), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / (B)(6)) 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 (B)(6) 2023, TH

  Patient problems: Aneurysm

  MAUDE report 17093006 ↗
• 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 16369018 ↗
• InjuryFeb 13, 2023Break; Migration; Break; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE GUIDING CATHETER (GC), AN 8F OPTIMO GUIDING CATHETER (TOKAI MEDICAL) WAS GUIDED TO THE RIGHT INTERNAL CAROTID ARTERY (ICA) VIA THE RIGHT FEMORAL ARTERY (FA) APPROACH. THE SOFIA ¿ 5F DISTAL ACCESS CATHETER (MICROVENTION) WAS GUIDED TO THE C1 SEGMENT OF THE ICA, FROM WHICH THE PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND A HEADWAY® 17 MICROCATHETER (MICROVENTION) WERE INSERTED. THE PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED TO THE A1 SEGMENT ¿ ANTERIOR CEREBRAL ARTERY (ACA). A PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / LOT# UNKNOWN) WAS IMPLANTED IN A HYBRID POSITION. THE HEADWAY® 17 MICROCATHETER MADE THE APPROACH TOWARD THE ANEURYSM VIA TRANS-CELL TECHNIQUE AND COIL EMBOLIZATION WAS INITIATED. THE COMPLAINT COIL, A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30701280) WAS USED, BUT IT BECAME PROTRUDED TO THE NECK SIDE. THE ISSUE WAS NOT RESOLVED DESPITE REWINDING SEVERAL TIMES. THE COIL WAS REMOVED ONCE FROM THE PATIENT¿S BODY. THE POSITION OF THE HEADWAY® 17 MICROCATHE

  Patient problems: Thromboembolism

  MAUDE report 16368903 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138270 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138269 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 50-YEAR-OLD FEMALE PATIENT (SUBJECT 953-008) WITH A HISTORY OF SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM), UNDERWENT COIL EMBOLIZATION OF A RUPTURED MIDLINE ANTERIOR COMMUNICATING ARTERY (ACOA) BIFURCATION ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6MM, DOME 4MM, MAXIMUM ANEURYSM DIAMETER 4MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 2MM. COIL EMBOLIZATION WAS PERFORMED WITH TWO (2) CERENOVUS COILS: A 2MM X 2CM GALAXY G3 XTRASOFT (GLX120202/L12961) AND A GALAXY G3 XTRASOFT 4MM X 8CM (GLX120408/L12875) VIA A PHENOM 17 MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 14.52% ANGIOSUITE PACKING DENSITY. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021 WITH AN MRS = 0. 180-DAY (6-MONTH) FOLLOW-UP VI

  Patient problems: Aneurysm

  MAUDE report 16087217 ↗
• MalfunctionNov 7, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE WITH RIGHT FEMORAL APPROACH WITH THE TARGET ANEURYSM LOCATED ON THE BASILAR TIP; A SEMI-JAILING TECHNIQUE WAS USED. THE FIRST COIL, A 5MM X 15CM GALAXY G3 COIL WAS WOUND INTO THE ANEURYSM WITH APPROXIMATELY 1 ¿ 2 LOOPS VIA THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER). A 2.5MM X 17MM LVIS¿ JR STENT (MICROVENTION) WAS PLACED USING A HEADWAY® 17 MICROCATHETER (MICROVENTION). AFTER THAT, THE 5MM X 15CM GALAXY G3 COIL WAS DETACHED ¿BY ALL WINDING.¿ THERE WAS RESISTANCE FELT WHEN INSERTING THE SECOND COIL, A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30704820). INSERTION WAS STOPPED IN THE MIDDLE AND THE Y-CONNECTOR PART WAS REMOVED; IT WAS THEN THAT THE UNRAVELED CONDITION WAS CONFIRMED. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY AND WAS REPLACED WITH A COMPETITOR COIL. A TOTAL OF SIX (6) COILS WERE IMPLANTED INTO THE TARGET LESION. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. ADDITIONAL CONCOMITANT DEVICES USED WERE A CHIKAI 14 200CM GUIDEWIRE (ASAHI-INTECC), 6FR 80CM ST FUBUKI GUIDE CATHETER (ASAHI INTECC), AND A SOFIA¿ 5FR 125CM ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749032 ↗
• MalfunctionAug 3, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR UNRUPTURED ANEURYSM AT THE ANTERIOR CEREBRAL ARTERY (ACA), A 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408, 30737316) AND ENPOWER CONTROL CABLE (ECB00018200, 30729888) WERE USED. THE COMPLAINT COIL WAS USED AND IMPLANTED AS FIRST COIL. HOWEVER, DETACHMENT ERROR OCCURRED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENTS OCCURRED DUE TO THE COMPLAINT COIL. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE IS A MICROCATHETER (EXSELSIOR SL10). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DETACHMENT ERROR WAS THAT THE DETACHMENT LED LIGHTED TO RED AND FAILED TO DETACH THE COIL. IT WAS CONFIRMED THAT THE COIL FAILED TO DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156378 ↗
• InjuryJul 26, 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 59-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, HYPERLIPIDEMIA, HYPERTENSION, ISCHEMIC STROKE, SMOKING, ALCOHOL ABUSE, AND LIVER STEATOSIS, UNDERWENT COIL EMBOLIZATION OF A RIGHT-SIDED UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 2 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 7.5MM, DOME 7.1MM, MAXIMUM ANEURYSM DIAMETER 5.7MM, NECK SIZE 4.1MM, AND THE DOME-TO-NECK RATIO OF 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.6MM. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF FIVE (5) CERENOVUS COIL: ONE 6MM X 20CM GALAXY G3 (GLY120620 / 30452213), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L16255), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30392744), ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308 / 30666660) AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208 / 30452207) VIA A 150CMX5CM, 2MARKERS, 45TIP PROWLER SELECT LPES MICROCATHETER (606S155FX / LOT# UNKNOWN). A 4MM X 24MM NEUROFORM ATLAS® STENT (STRYKER) WAS IMPLANTED. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15107536 ↗
• MalfunctionJul 26, 2022Break; Break

  AS REPORTED BY THE FIELD DURING A IMPLANTATION OF A 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408, L16656) WAS ATTEMPTED TO BE USED, BUT ITS SIZE DID NOT FIT TO THE TARGET LESION AND THE COMPLAINT PRODUCT WAS REMOVED FROM THE TARGET LESION. THE SHEATH INTRODUCER GOT DAMAGED DURING THE RE-SHEATH AND THE COIL WAS NOT ABLE TO BE RE-SHEATHED. THE COMPLAINT PRODUCT WAS ABLE TO BE REMOVED FROM THE PATIENT¿S BODY. AFTER THAT, A REPLACEMENT COIL WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCE. THERE WERE NO ADVERSE HEALTH EFFECTS, ETC. TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS A-COM. CONCOMITANT DEVICE WAS A MICROCATHETER (EXSELSIOR SL10). ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO REPORT OF THE PROCEDURE BEING DELAYED DUE TO THE EVENT. THERE WAS NO RESISTANCE ENCOUNTERED DURING THE PROCEDURE. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND TO BE SEVERELY KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103358 ↗
• MalfunctionApr 14, 2022Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA), BETWEEN THE COMMUNICATING SEGMENT AND THE CAROTID ARTERY, THE DEVICE WAS PURGED AND INSERTED INTO THE MICROCATHETER HUB. THE 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408 / K10708) WAS ADVANCED, BUT THE DEVICE WAS NOT OBSERVED / SEEN IN FLUOROSCOPY. AS A RESULT, THE MICROCATHETER WAS COMPLETELY WITHDRAWN AND THE GUIDEWIRE WITHOUT THE CORRESPONDING COIL WAS OBSERVED. SUBSEQUENTLY, IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE COIL WAS RELEASED IN THE MICROCATHETER WHILE IT WAS BEING ADVANCED. THE MICROCATHETER WAS CHANGED AND OTHER COILS WERE USED. ANEURYSM CLIPPING WAS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115132 ↗
• MalfunctionApr 11, 2022Stretched; Difficult to Advance; Premature Separation; Stretched; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A BRONCHIAL ARTERY EMBOLIZATION PROCEDURE, THE PHYSICIAN INTRODUCED THE 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408 / 30407119) THROUGH THE MICROCATHETER (UNSPECIFIED BRAND) AND PARTIALLY POSITIONED IT. AT THE TIME OF WITHDRAWING THE HYPOTUBE TO UNSHEATHE THE COIL GUIDE AND TO CONTINUE ADVANCING THE COIL, THE PHYSICIAN FELT A LOT OF RESISTANCE FOR WHICH HE CHOSE TO RECOVER. AT THE ATTEMPT TO RETRIEVE THE COIL, IT ELONGATED AND AS A RESULT, IT COULD NOT BE RESHEATHED. THE COIL SYSTEM WAS REMOVED. ONCE OUTSIDE THE PATIENT, IT WAS REPORTED THAT THE COIL BROKE AND BECAME SEPARATED FROM THE GUIDE WIRE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079427 ↗
• MalfunctionMar 4, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30466107) WAS THE THIRD COIL USED; IT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COMPLAINT COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT WAS OBSERVED THAT THE COIL WAS STRETCHED. THE PHYSICIAN USED ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675875 ↗
• MalfunctionJan 21, 2022Positioning Problem; Positioning Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. A 47-YEAR-OLD FEMALE PATIENT WITH NO REPORTED RELEVANT MEDICAL HISTORY UNDERWENT BALLOON ASSISTED COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM (HUNT & HESS GRADE 2) ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT HAD ANEURYSM RETREATMENT WITH STENT AND COILS. ON (B)(6) 2021, IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED RIGHT ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.7MM, DOME 4.2MM, MAXIMUM ANEURYSM DIAMETER 5.1MM, NECK SIZE 2.7MM, AND DOME-TO-NECK RATIO 1.6MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30513172) AND ONE 2MM X 6CM GALAXY G3 MINI (GLM920060 / 30490134) VIA AN SL-10® MICROCATHETER (STRYKER). THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED INTRA-OPERATIVELY. 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 WITH 22% ANGIOSUITE PACKING DENSITY. IMMEDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13319973 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  THE EVENT WAS REPORTED VIA THE (B)(6), A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE (CAD), AND ACTIVE SMOKING UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR CEREBRAL ARTERY (ACA) ON (B)(6) 2021 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. MEDICATION WAS ADMINISTERED AS TREATMENT. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE ACA BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 3.7MM, DOME 5MM, MAXIMUM ANEURYSM DIAMETER 5.3MM, NECK SIZE 2.9MM, AND DOME-TO-NECK RATIO OF 1.7MM. THE PARENT VESSEL DIAMETER WAS 2.4MM. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF TWO COMPETITOR (STRYKER) COILS AND A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / L13313) COIL VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). THERE WAS MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED TWICE DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF

  Patient problems: Thromboembolism

  MAUDE report 13153731 ↗
• MalfunctionSep 27, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 4MM X 8CM COIL (GLX120408, 30466107) WAS BEING USED AS THE THIRD COIL. THE PHYSICIAN DECIDED TO PULL IT OUT BECAUSE THE COIL'S SIZE WAS NOT APPROPRIATE WITH ANEURYSM. DURING RE-SHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE THE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537103 ↗
• MalfunctionAug 13, 2021Device Difficult to Setup or Prepare; Failure to Advance; Material Twisted/Bent; Device Difficult to Setup or Prepare; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR A SUBARACHNOID HEMORRHAGE (SAH), THE 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408 / 30392744) WAS USED, BUT THE COIL WAS IMPEDED IN THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE PHYSICIAN COMMENTED THAT THE ¿HOLDER SEEM TO COME OFF. IT WAS NOT ABLE TO BE INSERTED BECAUSE IT WAS NOT ABLE TO BE PEELED AWAY.¿ THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J JAPAN AFFILIATES AND INCLUDED IN THE COMPLAINT FILE ON 29 JULY 2021. BASED ON THE REVIEW OF THE PHOTOS BY THE PRODUCT ANALYSIS LAB COMPLETED ON 30 JULY 2021, THE 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408 / 30392744) IS OBSERVED TO BE IN KINKED CONDITION. BASED ON THE REVIEW OF THE PHOTOS, THE EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321413 ↗