GALAXY G3 GLX120208Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886704077763), received between Sep 18, 2017 and Mar 8, 2024 — classified as 3 deaths, 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Stretched” (14 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / 30742441) WAS IMPEDED IN THE MICROCATHETER AND COULD NOT PASS THROUGH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 08-MAR-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870719 ↗
• MalfunctionJan 17, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN USED TWO (2) 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT NUMBER (30697215) TO FILL THE ANEURYSM. IT WAS REPORTED THAT THE COILS WERE FOUND UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COILS AND SWITCHED TO NEW COILS TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530927 ↗
• MalfunctionJan 17, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN USED TWO (2) 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT NUMBER (30697215) TO FILL THE ANEURYSM. IT WAS REPORTED THAT THE COILS WERE FOUND UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COILS AND SWITCHED TO NEW COILS TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 17-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528457 ↗
• MalfunctionJan 12, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN USED TWO (2) 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT NUMBER (30579194) TO FILL THE ANEURYSM. IT WAS REPORTED THAT THE COILS WERE FOUND UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COILS AND SWITCHED TO NEW COILS TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509222 ↗
• MalfunctionJan 12, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN USED TWO (2) 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT NUMBER (30579194) TO FILL THE ANEURYSM. IT WAS REPORTED THAT THE COILS WERE FOUND UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COILS AND SWITCHED TO NEW COILS TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509220 ↗
• MalfunctionOct 20, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION TO TREAT A TYPE 2 ENDOLEAK, THE COMPLAINT DEVICE, A 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / 30871984) WAS PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND USED. THE COIL SIZE DID NOT FIT SO IT WAS RETRIEVED AND RE-INSERTED AGAIN, BUT IT COULD NOT BE INSERTED. AN ATTEMPT TO RESHEATH THE COIL WAS MADE BUT IT COULD NOT BE RESHEATHED AS THE RESHEATHING TOOL GOT BROKEN AND COULD NOT BE USED. IT WAS REPLACED WITH A NEW COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS NOT MAINTAINED. THE LOCATION OF THE LESION IS NOT KNOWN. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 12-SEP-2023, ADDITIONAL CLARIFYING INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NO RESISTANCE. THERE WAS ONE ATTEMPT TO RE-INSERT THE COIL . NO FURTHER INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 20-OCT-2023. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981071 ↗
• MalfunctionMar 30, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A TYPE II ENDOLEAK, AFTER THE GUIDING CATHETER WAS DELIVERED FROM THE LEFT INTERNAL ILIAC ARTERY (IIA) TO THE TYPE II ENDOLEAK, A CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL) WAS DELIVERED TO THE TARGET LESION AND COIL EMBOLIZATION WAS INITIATED. SEVERAL DELTA COILS WERE IMPLANTED AND ONE OF THE COMPLAINT COILS, A 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208 / 30871979) WAS USED BUT IT BECAME IMPEDED IN THE MICROCATHETER AND WAS UNABLE TO BE DELIVERED. IT WAS REPLACED WITH ANOTHER 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT (30871979) BUT THE SAME ISSUE OCCURRED AND THE COIL WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE DELIVERED. IT WAS REPLACED WITH A DELTA COIL (UNSPECIFIED SIZE) AND THIS DELTA COIL WAS DELIVERED TO THE TARGET LESION. IT WAS REPORTED THAT THE LEFT TYPE II ENDOLEAK WAS EMBOLIZED. THE GUIDING CATHETER WAS THEN DELIVERED TO THE TYPE II ENDOLEAK FROM THE RIGHT IIA. THE MICROCATHETER WAS DELIVERED AND COIL EMBOLIZATION WAS INITIATED. 4MM X 15CM DELTA COIL(S) WERE IMPLANTED AND ONE COMPLAINT COIL, A 3MM X 12CM DELTAFILL 18 (DLF180312 / 30810117) WAS USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16650793 ↗
• MalfunctionMar 30, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A TYPE II ENDOLEAK, AFTER THE GUIDING CATHETER WAS DELIVERED FROM THE LEFT INTERNAL ILIAC ARTERY (IIA) TO THE TYPE II ENDOLEAK, A CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL) WAS DELIVERED TO THE TARGET LESION AND COIL EMBOLIZATION WAS INITIATED. SEVERAL DELTA COILS WERE IMPLANTED AND ONE OF THE COMPLAINT COILS, A 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208 / 30871979) WAS USED BUT IT BECAME IMPEDED IN THE MICROCATHETER AND WAS UNABLE TO BE DELIVERED. IT WAS REPLACED WITH ANOTHER 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT (30871979) BUT THE SAME ISSUE OCCURRED AND THE COIL WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE DELIVERED. IT WAS REPLACED WITH A DELTA COIL (UNSPECIFIED SIZE) AND THIS DELTA COIL WAS DELIVERED TO THE TARGET LESION. IT WAS REPORTED THAT THE LEFT TYPE II ENDOLEAK WAS EMBOLIZED. THE GUIDING CATHETER WAS THEN DELIVERED TO THE TYPE II ENDOLEAK FROM THE RIGHT IIA. THE MICROCATHETER WAS DELIVERED AND COIL EMBOLIZATION WAS INITIATED. 4MM X 15CM DELTA COIL(S) WERE IMPLANTED AND ONE COMPLAINT COIL, A 3MM X 12CM DELTAFILL 18 (DLF180312 / 30810117) WAS USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16650791 ↗
• MalfunctionMar 2, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A RENTAL ARTERY ANEURYSM, TWO GALAXY G3 XSFT HEL 2MM X 8CM COILS (GLX120208, 30677937) WERE USED AS THE EIGHTH AND NINTH COIL. THESE COMPLAINT COILS WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS INTENSIVE RESISTANCE FELT WHEN ONE OF THE COMPLAINT COILS WAS ADVANCED THROUGH A MICROCATHETERS (LEONISMOVA). THE COMPLAINT COIL BECAME STUCK ON THE MICROCATHETER (MC) AND WHEN REMOVED IT BECAME UNRAVELED. THE MICROCATHETER WAS FLUSHED AGAIN AND THE SECOND COMPLAINT COIL WAS USED BUT THE SAME ISSUE OCCURRED. THESE COMPLAINT COILS GOT DAMAGED. THE PROCEDURE WAS COMPLETED AFTER ANOTHER COIL (DIFFERENT LOT NUMBER) WAS USED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466425 ↗
• MalfunctionMar 2, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A RENTAL ARTERY ANEURYSM, TWO GALAXY G3 XSFT HEL 2MM X 8CM COILS (GLX120208, 30677937) WERE USED AS THE EIGHTH AND NINTH COIL. THESE COMPLAINT COILS WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS INTENSIVE RESISTANCE FELT WHEN ONE OF THE COMPLAINT COILS WAS ADVANCED THROUGH A MICROCATHETERS (LEONISMOVA). THE COMPLAINT COIL BECAME STUCK ON THE MICROCATHETER (MC) AND WHEN REMOVED IT BECAME UNRAVELED. THE MICROCATHETER WAS FLUSHED AGAIN AND THE SECOND COMPLAINT COIL WAS USED BUT THE SAME ISSUE OCCURRED. THESE COMPLAINT COILS GOT DAMAGED. THE PROCEDURE WAS COMPLETED AFTER ANOTHER COIL (DIFFERENT LOT NUMBER) WAS USED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466424 ↗
• 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 01208-010), 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.

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987050 ↗
• MalfunctionOct 12, 2022Separation Failure; Separation Failure

  AS REPORTED VIA THE STERLING STUDY, 2MM X 8CM GALAXY G3 XSFT HEL COIL (GLX120208, 30485189) FAILED TO DETACH. PER THE CASE REPORT FORMS (CRF), THE DEVICE DEFICIENCY DID NOT LEAD TO A SERIOUS ADVERSE DEVICE EFFECT (SADE) OR AN UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT (USADE). NO ACTION WAS TAKEN, NO INTERVENTION HAD NOT BEEN MADE AND NO CIRCUMSTANCES HAD BEEN LESS FORTUNATE. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2021 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 6MM, DOME 4MM, MAXIMUM ANEURYSM DIAMETER 6.7MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2021. A TOTAL OF FOUR CERENOVUS (2 GALAXY G3, 1 GALAXY G3 XSFT, & 1 GALAXY G3 MINI) COILS WERE IMPLANTED DURING THE PROCEDURE WITH 34% ANGIOSUITE PACKING DENSITY. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. THE PARENT VESSEL DIAMETER WAS 2.3MM. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589334 ↗
• MalfunctionAug 31, 2022Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE INTERNAL MAMMARY ARTERY, THE DELIVERY OF A 2MM X 8CM GALAXY G3 XSFT HEL COIL (GLX120208, 30666658) WAS PERFORMED, BUT THE COMPLAINT PRODUCT BEHAVED AS IF IT WAS UNRAVELED IN THE EXSELSIOR 1018 MICROCATHETER (MC). THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER EQUIVALENT ONE. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326899 ↗
• InjuryJul 26, 2022Migration; Migration

  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 24-MAY-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 HELICAL (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 TREATMEN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15107431 ↗
• MalfunctionJun 7, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FILED, A MICROCATHETER (BREAKTHROUGH) WAS DELIVERED TO THE ENDOLEAK LESION, AND COIL EMBOLIZATION WAS PERFORMED. WHEN ACCESSING TO INFERIOR MESENTERIC ARTERIAL BY THE ENDOLEAK AND EMBOLIZING, A GALAXY G3 XSFT HEL 2MM X 8CM (GLX120208, 30611672) WAS SELECTED, BUT IT WAS TOO LONG. THEREFORE, THE SIZE WAS CHANGED, AND IMPLANTATION WAS PERFORMED. AFTER THAT, IT WAS STORED, AND COIL WAS USED AGAIN BECAUSE THE BLOOD VESSEL WAS PRECEDED BY A MGW WHEN ACCESSING THE LUMBAR ARTERY. AT THE FIRST USE, THERE WAS NO PROBLEM WHEN THE ENERGIZED POWER WAS CONFIRMED, THEREFORE, THE COIL WAS DELIVERED TO THE BLEEDING SITE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DETACH IT, THE ENERGIZED BUTTON WAS NOT ILLUMINATED ALTHOUGH IT WAS CONNECTED. WHEN IT WAS CONNECTED AND REMOVED MANY TIMES, THE ENERGIZED BUTTON WAS ILLUMINATED MOMENTARILY, BUT THE CONDITION OF CONTACT WAS POOR. DURING STORAGE, THE HUB PART WAS NOT ATTACHED TO THE LIQUID, AND THE CABLE REMAINED AS IT WAS WHEN ONE CONNECTING CABLE WAS USED. THE PHYSICIAN REPLACED IT WITH AN INTERLOCK AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS LUMBAR ARTERY. CONCOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14623616 ↗
• MalfunctionJun 6, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A MENINGIOMA EMBOLIZATION, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A SHEATH (6FR). THE GUIDING CATHETER WAS APPROACHED TO THE LEFT COMMON CAROTID ARTERY (LT-CCA). A HEADWAY 21 MICROCATHETER (MC) WAS ADVANCED TO THE MIDDLE MENINGEAL ARTERY (MMA) FROM THE LEFT EXTERNAL CAROTID ARTERY (LT-ECA), AND THE EMBOLIZATION WAS STARTED. AFTER THE EMBOSSED-FAIR 300-500 WAS IMPLANTED, A 2MM X 8CM GALAXY G3 COIL (GLX120208, L16361) WAS USED FOR THE ADDITIONAL EMBOLIZATION. THE PHYSICIAN TRIED TO INSERT THE GALAXY G3 INTO THE MICROCATHETER, BUT THE GALAXY G3 BECAME ¿STUCK¿ JUST A LITTLE WAY FROM THE HUB. THE DELIVERY WIRE SLOWLY PULLED BUT THE DEVICE BECAME UNRAVELED. AFTER THE DELIVERY WIRE WAS PULLED MORE SLOWLY, THE COIL WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS ABLE TO BE PROCEEDED. WHEN THE GUIDE WIRE WAS INSERTED INTO THE MICROCATHETER JUST IN CASE, THERE WAS NO RESISTANCE, THEREFORE, ANOTHER GALAXY (SAME PRODUCT NUMBER, DIFFERENT LOT) WAS INSERTED. THE PRODUCT WAS USED WITHOUT ANY PROBLEM. THE EMBOLIZATION/PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS LT-MMA. CONCOMITANT DEVICES ALSO INCLUDE A GUIDING CATHETER (SLIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601783 ↗
• InjuryApr 5, 2022Adverse 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 PAST MEDICAL HISTORY OF CONTROLLED HYPERTENSION UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6) 2021. THE PATIENT EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6)2022. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6) 2022 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. SHE SUBSEQUENTLY UNDERWENT ANEURYSM RETREATMENT DUE TO RESIDUAL ANEURYSM ON (B)(6) 2022. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2021 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 6MM, DOME 4MM, MAXIMUM ANEURYSM DIAMETER 6MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2021. A TOTAL OF FOUR CERENOVUS COILS WERE IMPLANTED DURING THE PROCEDURE: GALAXY G3 7MM X 21CM (GLY120721, 30470358), GALAXY G3 XSFT HEL 2MM X 8CM (GLX120208, 3045189), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30504557) AND GALAXY G3 MIN

  Patient problems: Aneurysm

  MAUDE report 14014605 ↗
• InjuryFeb 7, 2022Separation Failure; Separation Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ARTERY ANEURYSM, A 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/30483246) WAS SELECTED FOR USE AS THE SECOND COIL, BUT THE COIL FAILED TO DETACH. THE CONCOMITANT CONTROL CABLE AND DETACHMENT CONTROL BOX (DCB) WERE REPLACED, BUT THE ISSUE CONTINUED. THE ¿PLUG CONTACTS¿ WERE VISUALLY INSPECTED AND NO ISSUES WERE FOUND. THE PHYSICIAN TRIED TO DISASSEMBLE THE PLUG, BUT THIS ATTEMPT WAS NOT SUCCESSFUL. THROUGH THIS ACTION, THE PLASTIC JACKET OF THE PLUG BECAME SOMEWHAT ERODED. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE COIL WITH THE SOLITAIRE AB STENT (MEDTRONIC) DETACHMENT SYSTEM AND RUBBED OFF THE INSULATION AT THE COIL WIRE WITH THE POSITIVE CONTACT, MINUS ELECTRODE TO NEEDLE IN THE BAR. THIS WAS NOT SUCCESSFUL. THE PHYSICIAN ULTIMATELY DECIDED TO REMOVE THE COIL FROM THE PATIENT. THE FIRST COIL, A 4MM X 11.5CM 3D FRAMING COIL, REMAINED STABLE IN THE ANEURYSM. THE PHYSICIAN THEN IMPLANTED TWO GALAXY G3 COILS (2MM X 6CM AND 2MM X 4CM) WITHOUT ANY PROBLEMS DURING DETACHMENT. THE PHYSICIAN CHECKED THE ANEURYSM AND OBSERVED A THROMBUS AT THE NECK OF THE ANEURYSM, WHICH WAS CONSIDERED TO BE CAUSED B

  Patient problems: Thromboembolism

  MAUDE report 13470516 ↗
• DeathDec 17, 2021Adverse 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) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, SMOKING (PREVIOUS), AND ATHEROSCLEROSIS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 53.6 MM ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPIRED SECONDARY TO AAA RUPTURE 300 DAYS FOLLOWING THE PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA FOR ENDOLEAK REPAIR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. THE STUDY PROCEDURE OCCURRED 2,582 DAYS AFTER THE INITIAL EVAR OF AAA. A TOTAL OF 8 SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE LUMBAR ARTERY: THREE 2 MM X 2 CM GALAXY G3 XSFT (GLX120202/UNKNOWN LOT NUMBER), TWO 2 MM X 4 CM GALAXY G3 XSFT HEL (GLX120204/UNKNOWN LOT NUMBER), AND THREE 2 MM X 8 CM GALAXY G3 XSFT HEL (GLX120208/UNKNOWN LOT NUMBER). FLUOROSCOPY TIME WAS 33 MINUTES. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED FOUR DAYS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 13025372 ↗
• DeathDec 17, 2021Adverse 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) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, SMOKING (PREVIOUS), AND ATHEROSCLEROSIS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 53.6MM ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPIRED SECONDARY TO AAA RUPTURE 300 DAYS FOLLOWING THE PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA FOR ENDOLEAK REPAIR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. THE STUDY PROCEDURE OCCURRED 2,582 DAYS AFTER THE INITIAL EVAR OF AAA. A TOTAL OF 8 SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE LUMBAR ARTERY: THREE 2MM X 2CM GALAXY G3 XSFT (GLX120202/UNKNOWN LOT NUMBER), TWO 2MM X 4CM GALAXY G3 XSFT HEL (GLX120204/UNKNOWN LOT NUMBER), AND THREE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/UNKNOWN LOT NUMBER). FLUOROSCOPY TIME WAS 33 MINUTES. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED FOUR DAYS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 13025371 ↗
• DeathDec 17, 2021Adverse 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) MALE PATIENT (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, SMOKING (PREVIOUS), AND ATHEROSCLEROSIS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 53.6MM ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPIRED SECONDARY TO AAA RUPTURE 300 DAYS FOLLOWING THE PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA FOR ENDOLEAK REPAIR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. THE STUDY PROCEDURE OCCURRED 2,582 DAYS AFTER THE INITIAL EVAR OF AAA. A TOTAL OF 8 SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE LUMBAR ARTERY: THREE 2MM X 2CM GALAXY G3 XSFT (GLX120202/UNKNOWN LOT NUMBER), TWO 2MM X 4CM GALAXY G3 XSFT HEL (GLX120204/UNKNOWN LOT NUMBER), AND THREE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/UNKNOWN LOT NUMBER). FLUOROSCOPY TIME WAS 33 MINUTES. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED FOUR DAYS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 13025367 ↗
• MalfunctionNov 16, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A PANCREATIC ARCADE ARTERY ANEURYSM, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / 30504546) WAS INSERTED INTO A CONCOMITANT CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL) AND THE COIL WAS DELIVERED TO THE LESION. IT WAS REPORTED THAT IT WAS ¿IMPOSSIBLE¿ TO PUSH THE DELIVERY WIRE BACK AND FORTH WHEN THE COIL PART CAME OUT FROM THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN MANAGED TO REMOVE THE COIL WITH FORCE; THE PHYSICIAN OBSERVED THE REMOVED COMPLAINT DEVICE AND THE JUNCTION PART OF THE WIRE AND THE COIL WAS UNRAVELED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED. THE PHYSICIAN COMMENTED THAT IT WAS UNKNOWN IF THE CAUSE OF THE COIL UNRAVELING WAS DUE TO THE MICROCATHETER OR TO THE COMPLAINT COIL. HOWEVER, THE MICROCATHETER WAS USED AFTER THE COMPLAINT COIL WAS REMOVED. THEREFORE, IT WAS HIGHLY POSSIBLE THAT THE COMPLAINT COIL MALFUNCTIONED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824709 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCA) COIL EMBOLIZATION PROCEDURE, A 2MM X 8CM GALAXY G3 COIL (GLX120208, 30483247) WAS ATTEMPTED TO BE DETACHED. HOWEVER, THE LIGHT DID NOT ILLUMINATE, AND THE COMPLAINT COIL WAS NOT ABLE TO BE DETACHED. IT WAS REPLACED WITH ANOTHER NEW COIL AND IT DETACHED. THE ACTUAL COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE SAME DETACHABLE CONTROL BOX (DCB) AND THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WAS NO NECK REMODELING UTILIZED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343762 ↗
• MalfunctionAug 2, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR AN ENDOLEAK TYPE II, A 160CM CARNELIAN MARVEL MICROCATHETER, TOKAI MEDICAL PRODUCTS WAS USED. THE HUB OF A 2MMX8CM GALAXY G3 COIL (GLX120208, 30464440) WITH AN ENPOWER CONTROL CABLE (ECB00018200, 30578774) AND A DETACHABLE CONTROL BOX 2 (DCB2) WERE CONNECTED. THE PRE-DETACHMENT ELECTRICAL CHECK WAS DONE, AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. THE DETACHMENT BUTTON OF THE COMPLAINT CABLE WAS PRESSED BUT THE COMPLAINT COIL WAS NOT ABLE TO BE DETACHED. THE DCB2 WAS REPLACED WITH ANOTHER BOX BUT THE SAME ISSUE CONTINUED. THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER COMPLAINT CABLE, BUT THE SAME ISSUE CONTINUED. THE DETACHMENT BUTTON OF THE DCB2 WAS PRESSED BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH A COMPETITOR¿S COIL AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259882 ↗
• MalfunctionJul 15, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A BRONCHIAL-ARTERY EMBOLIZATION (BAE) PROCEDURE, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / 30452207) WAS USED AS THE FINAL COIL AFTER THREE COILS WERE IMPLANTED. THE COMPLAINT COIL WAS ABLE TO EMBOLIZE AS INTENDED, BUT IT COULD NOT BE DETACHED EVEN THOUGH THE ENPOWER CONTROL CABLE WAS PRESSED SEVERAL TIMES. DUE THE LESION BEING SLIGHTLY SEVERE, THE PHYSICIAN USED THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER AND SUCCESSFULLY REMOVED THE COIL WITH THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE PROCEDURE WAS COMPLETED. THE COMPLAINT COIL IS NOT AVAILABLE TO BE RETURNED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178598 ↗