GALAXY G3 GLX120308Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886704077701), received between Feb 16, 2017 and Dec 18, 2025 — classified as 17 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Product Quality Problem; Stretched; Product Quality Problem; Stretched

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE ENCR402312, LOT NUMBER 9518158) WAS ADVANCED TO THE TARGET POSITION AND BEGAN TO RELEASE, BUT THE DISTAL MARKERS CONVERGED AND THE STENT COULD NOT BE OPENED. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO CONTINUE THE SURGERY, WITHOUT REPLACING THE UNSPECIFIED MICROCATHETER. WHEN THE GALAXY G3 XSFT 3MM X 8CM COIL (PRODUCT CODE GLX120308, LOT NUMBER 0152503S) WAS USED TO FILL THE TARGET SITE, IT COULD NOT BE ROTATED AS EXPECTED; UPON RETRACTION, THE COIL WAS FOUND TO BE UNRAVELED AND STRETCHED. THE PHYSICIAN REPLACED THE COIL TO COMPLETE THE PROCEDURE, AND THE COIL MICROCATHETER WAS NOT REPLACED. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT, AND NO OBSERVABLE CLINICAL SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839335 ↗
• MalfunctionJan 7, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE CORE WIRE COIL ON THE 3MM X 8CM GALAXY G3 XSFT (GLX120308 / 30860247) WAS KINKED DURING RESHEATHING. A PHOTO WAS INCLUDED IN THE COMPLAINT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE PRODUCT ANALYSIS TEAM COMPLETED THE REVIEW OF THE PHOTO ON 24-DEC-2024. BASED ON THE REVIEW OF THE PHOTO INCLUDED IN THE COMPLAINT, THE 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 21097881 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE (SUBJECT: (B)(6) WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, HEADACHES, CONTROLLED HYPERTENSION, PRESENTED WITH AN UNRUPTURED ANEURYSM, AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2024. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT BIFURCATION ANTERIOR CIRCULATION: MIDDLE CEREBRAL ARTERY (MCA): HEIGHT: 4MM, DOME: 2MM, MAXIMUM ANEURYSM DIAMETER: 3.9MM, NECK SIZE: 2.8MM, AND DOME-TO-NECK RATIO: 0.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE GALAXY G3 XSFT 3MM X 8CM (GLX120308/ 30670800), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2.5MM X 5.5CM (GLM925055/ 30599732), AND ONE GALAXY G3 MINI 1.5MM X 2.5CM (GLM915025/ 30797241) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). TWO NEUROFORM ATLAS STENTS (STRYKER) WERE IMPLANTED AS WELL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREA

  Patient problems: Aneurysm

  MAUDE report 20858211 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, HEADACHES, CONTROLLED HYPERTENSION, PRESENTED WITH AN UNRUPTURED ANEURYSM, AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2024. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT BIFURCATION ANTERIOR CIRCULATION: MIDDLE CEREBRAL ARTERY (MCA): HEIGHT: 4MM, DOME: 2MM, MAXIMUM ANEURYSM DIAMETER: 3.9MM, NECK SIZE: 2.8MM, AND DOME-TO-NECK RATIO: 0.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE GALAXY G3 XSFT 3MM X 8CM (GLX120308/ 30670800), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2.5MM X 5.5CM (GLM925055/ 30599732), AND ONE GALAXY G3 MINI 1.5MM X 2.5CM (GLM915025/ 30797241) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). TWO NEUROFORM ATLAS STENTS (STRYKER) WERE IMPLANTED AS WELL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREA

  Patient problems: Aneurysm

  MAUDE report 20857077 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE (SUBJECT (B)(6) ) WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, HEADACHES, CONTROLLED HYPERTENSION, PRESENTED WITH AN UNRUPTURED ANEURYSM, AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2024. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT BIFURCATION ANTERIOR CIRCULATION: MIDDLE CEREBRAL ARTERY (MCA): HEIGHT: 4MM, DOME: 2MM, MAXIMUM ANEURYSM DIAMETER: 3.9MM, NECK SIZE: 2.8MM, AND DOME-TO-NECK RATIO: 0.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE GALAXY G3 XSFT 3MM X 8CM (GLX120308/ 30670800), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2.5MM X 5.5CM (GLM925055/ 30599732), AND ONE GALAXY G3 MINI 1.5MM X 2.5CM (GLM915025/ 30797241) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). TWO NEUROFORM ATLAS STENTS (STRYKER) WERE IMPLANTED AS WELL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TRE

  Patient problems: Aneurysm

  MAUDE report 20856102 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE (SUBJECT (B)(6) WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, HEADACHES, CONTROLLED HYPERTENSION, PRESENTED WITH AN UNRUPTURED ANEURYSM, AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6)2024. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT BIFURCATION ANTERIOR CIRCULATION: MIDDLE CEREBRAL ARTERY (MCA): HEIGHT: 4MM, DOME: 2MM, MAXIMUM ANEURYSM DIAMETER: 3.9MM, NECK SIZE: 2.8MM, AND DOME-TO-NECK RATIO: 0.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE GALAXY G3 XSFT 3MM X 8CM (GLX120308/ 30670800), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2.5MM X 5.5CM (GLM925055/ 30599732), AND ONE GALAXY G3 MINI 1.5MM X 2.5CM (GLM915025/ 30797241) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). TWO NEUROFORM ATLAS STENTS (STRYKER) WERE IMPLANTED AS WELL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREATM

  Patient problems: Aneurysm

  MAUDE report 20855316 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, HEADACHES, CONTROLLED HYPERTENSION, PRESENTED WITH AN UNRUPTURED ANEURYSM, AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2024. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT BIFURCATION ANTERIOR CIRCULATION: MIDDLE CEREBRAL ARTERY (MCA): HEIGHT: 4MM, DOME: 2MM, MAXIMUM ANEURYSM DIAMETER: 3.9MM, NECK SIZE: 2.8MM, AND DOME-TO-NECK RATIO: 0.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE GALAXY G3 XSFT 3MM X 8CM (GLX120308/ 30670800), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2MM X 6CM (GLM920060/ 30830574), ONE GALAXY G3 MINI 2.5MM X 5.5CM (GLM925055/ 30599732), AND ONE GALAXY G3 MINI 1.5MM X 2.5CM (GLM915025/ 30797241) VIA AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). TWO NEUROFORM ATLAS STENTS (STRYKER) WERE IMPLANTED AS WELL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREA

  Patient problems: Aneurysm

  MAUDE report 20855278 ↗
• MalfunctionSep 30, 2024Material Separation; Positioning Problem; Material Separation; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A POSTERIOR CIRCULATION, BASILAR ARTERY ANEURYSM, DURING THE ANEURYSM FILLING, ABOUT HALF OF THE 3MM X 8CM GALAXY G3 XSFT COIL (GLX120308 / 30789565) IN THE TARGET SITE, THE SHAPE OF THE COIL WAS NOT SATISFACTORY SO THE COIL WAS UNABLE TO BE USED TO CONTINUE FILLING THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL, BUT THE COIL BROKE. THE PHYSICIAN REMOVED THE MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) AND THE BROKEN COIL COMPONENT IN THE MICROCATHETER FROM THE PATIENT. THE REST OF THE COIL COMPONENT THAT BROKE REMAINED IN THE ANEURYSM. A PROCEDURE IMAGE WAS INCLUDED IN THE COMPLAINT THAT DEPICTS THIS. THE PHYSICIAN REPLACED THE COIL AND THE MICROCATHETER TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS REPORTEDLY PROLONGED BY APPROXIMATELY 10 MINUTES. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE ANEURYSM RUPTURED. THE PATIENT UNDERWENT A CRANIOTOMY AND IS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE IMAGE INCLUDED IN THE COMPLAINT WILL UNDERGO INDEPENDENT PHYSICIAN REVIEW. ON 23-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS A 54-YEAR-OLD MALE.

  Patient problems: Ruptured Aneurysm; Vasoconstriction

  MAUDE report 20338100 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL SHEATH OF THE COMPLAINT DEVICE, A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / 30820681) WAS BROKEN DURING RESHEATHING. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 19-SEP-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 20260892 ↗
• MalfunctionSep 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL INTRODUCER OF THE COMPLAINT DEVICE, A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / 30860246) WAS BROKEN DURING THE RECAPTURE ATTEMPT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 05-SEP-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 20153339 ↗
• MalfunctionAug 15, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 3MM X 8CM COIL FAILED TO DETACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990671 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987080 ↗
• InjuryDec 7, 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 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BASED ON THE MODIFIED INFORMATION RECEIVED ON (B)(6) 2022, COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING COILS WERE IMPLANTED: AN 8MM X 16.1CM MICRUSFRAME 10 (MFR100816 / L15372), A 5MM X 15CM GALAXY G3 (GLY120515 / 30517632), A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / K10121), A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / L16158), A 5MM X 15CM GALAXY G3 (GLY120515 / K10721), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / K10380), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / L16495) VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGIN

  Patient problems: Aneurysm; Ischemia Stroke

  MAUDE report 15936860 ↗
• InjurySep 20, 2022Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2022, DURING A PULSERIDER STENT-ASSISTED COIL EMBOLIZATION WITH THE TARGET ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS DELIVERED TO THE TARGET REGION AND DEPLOYED. THE PHYSICIAN ATTEMPTED TO FRAME THE ANEURYSM BY USING A 4MM X 8CM MICRUSFRAME 14 COIL ((B)(4) / LOT# UNKNOWN). HOWEVER, THE COIL DID NOT FIT WELL, SO THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. ON THE SECOND ATTEMPT, THE PHYSICIAN ATTEMPTED TO COMPLETE THE FRAMING BY CHANGING THE MICROCATHETER SHAPE AND THE COIL SIZE / TYPE WITH THE FOLLOWING COILS: A 3.5MM X 9CM GALAXY G3 XSFT (GLX123509 / LOT# UNKNOWN), A 3MM X 8CM HYDROSOFT® COIL (MICROVENTION-TERUMO), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / LOT# UNKNOWN). HOWEVER THESE COILS ALSO DID NOT FIT WELL SO THEY WERE REMOVED FROM THE PATIENT¿S BODY. IN ADDITION, THE PHYSICIAN ALSO NOTICED THAT THE DEPLOYED PULSERIDER ANRD DID NOT SUFFICIENTLY COVER THE ANEURYSM NECK, THEREFORE, THE PHYSICIAN ALSO REMOVED THE PULSERIDER ANRD. ON THE THIRD ATTEMPT, THE PHYSICIAN TRIED THE BALLOON-ASSIST TECHNIQUE. THE PHYSICIA

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15456505 ↗
• 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 15107583 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 42-YEAR-OLD FEMALE (B)(6) WITH NO TARGETED MEDICAL HISTORY, EXCEPT BEING A SMOKER, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT ANEURYSM IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY ON (B)(6) 2021. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2021, THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.1MM, DOME 6.3MM, MAXIMUM ANEURYSM DIAMETER 6.3MM, NECK SIZE 1.9MM, AND THE DOME-TO-NECK RATIO OF 3.3MM. THE PARENT VESSEL DIAMETER WAS NOT DONE. THE FOLLOWING COILS WERE IMPLANTED VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC): ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/ 30532733), ONE 4MM X 12CM GALAXY G3 (GLY120412/30541491), ONE 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535/30546472), ONE 2MM X 4MM GALAXY G3 MINI (GLM920040/30558132), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/30558365), AND ONE 2MM X 2MM GALAXY G3 XSFT (GLX120202/L16466). ONE 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525/30541484) WAS USED, BUT NOT IMPLANTED. MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED A TOTAL OF THREE TIMES. HEPARIN WAS ADMINISTERED DU

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516792 ↗
• MalfunctionMay 20, 2022Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA), THE PHYSICIAN INTRODUCED A 3MM X 8CM GALAXY G3 COIL (GLX120308, 30670800) INTO THE ANEURYSM AND ATTEMPTED TO DETACH. COIL DID NOT DETACH AFTER MULTIPLE TRIES WHILE ALSO ADJUSTING THE POSITION OF THE COIL IN THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN REMOVED THE COIL WITHOUT ANY OTHER ISSUES OR ADDITIONAL INTERVENTION AND USED A NEW COIL TO PLACE IN THE ANEURYSM. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COIL HAD BEEN PACKED IN THE ORIGINAL PACKAGE AND BOX. ADDITIONAL INFORMATION INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THE ANEURYSM WAS APPROXIMATELY 6MM(W)X4MM(H). FUSIFORM TYPE IN A2 SECTION OF ACA. THERE WAS A THREE-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14452491 ↗
• InjuryApr 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6) MALE PATIENT WITH A HISTORY OF CLASS 2 OBESITY (BMI 35 KG/M2) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH HUNT & HESS GRADE 1 ON (B)(6) 2021. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.9MM, DOME 3.5MM, MAXIMUM ANEURYSM DIAMETER 5MM, NECK SIZE 2.4MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS SPECTRA COILS: A 5 MM X 15 CM GALAXY G3 (GLY120515 / 30513182), A 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L14664), A 3 MM X 6 CM GALAXY G3 XSFT (GLX120306 / 30490139), A 2 MM X 6 CM GALAXY G3 MINI (GLM920060 / 30392250), A 1.5 MM X 2 CM GALAXY G3 MINI (GLM915020 / L14683), AND A 2 MM X 4 CM (GLM920040 / 30379814) VIA AN SL-10® MICROCATHETER (STRYKER). MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED THREE TIMES DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED INTRAOPERATIVELY. 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 69% ANGIOSUITE PACKING DENSITY

  Patient problems: Aneurysm

  MAUDE report 14079083 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) FEMALE PATIENT WITH A HISTORY OF CONGESTIVE HEART FAILURE (CHF), DIABETES, CONTROLLED HYPERTENSION, HYPOTHYROIDISM, GASTROESOPHAGEAL REFLUX DISEASE (GERD), SLEEP APNEA, LIVER CIRRHOSIS, ESOPHAGEAL VARICES, OSTEOPOROSIS, IDIOPATHIC PULMONARY FIBROSIS (IPF), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND CLASS 1 OBESITY (BMI 30 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM 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 THE FOLLOWING DAY WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 2, UNCHANGED FROM BASELINE. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE ACOM BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 9.7MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 6.6MM, NECK SIZE 3.6MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 10MM X 30CM

  Patient problems: Thromboembolism

  MAUDE report 13090772 ↗
• MalfunctionDec 13, 2021Fracture; Fracture

  AS REPORTED BY THE FIELD, UPON REMOVAL OF A GALAXY G3 XSFT 3MM X 8CM COIL (GLX120308, 30526855), THE HYPO TUBE RUPTURED. MAKING THE DEVICE IMPOSSIBLE TO USE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983040 ↗
• 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 12207740 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020 REQUIRING REPEAT COIL EMBOLIZATION ON 09-JUN-2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX

  Patient problems: No Code Available

  MAUDE report 10239768 ↗
• MalfunctionMay 27, 2020Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE COIL OF A 3MM X 8CM GALAXY G3 XSFT COIL (GLX120308, L12913) SPONTANEOUSLY DETACHED PRIOR TO USE, WHILE STILL IN MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY. THE DEVICE WAS REPLACED BY A SAME LIKE PRODUCT. THERE WAS NO PROCEDURAL DELAYS AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE. THE PRODUCT WAS STORED ACCORDING TO LABELING INSTRUCTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093087 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CONTROLLED HYPERTENSION AND APICAL HYPERTROPHIC CARDIOMYOPATHY UNDERWENT COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT MCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 4.3MM, MAXIMUM ANEURYSM DIAMETER 5.7MM, NECK SIZE 3.4MM, AND DOME-TO-NECK RATIO 1.3MM. PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 5MM X 15CM GALAXY G3 (GLY120515/L12907), ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L15707), AND ONE 2MM X 4CM GALAXY G3 XSFT HEL (GLX120204/L11837) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 30% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED ONE TIME DURING THE PROCEDURE (PENDING CLARIFICATION). IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPL

  Patient problems: Infarction, Cerebral

  MAUDE report 10086880 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, IT WAS REPORTED VIA THE STERLING STUDY THAT THE (B)(6) FEMALE PATIENT EXPERIENCED ¿TINY STROKES.¿ THE PATIENT IS A CURRENT SMOKER WITH A HISTORY OF DIABETES, HEADACHES, HYPERLIPIDEMIA, AND HYPERTENSION PRESENTED WITH A RUPTURED MIDLINE, BIFURCATION ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6) 2019. THE ANEURYSM WAS 6.8 MM IN HEIGHT WITH A 3.8 MM DOME, MAXIMUM NECK SIZE WAS 6.8 MM, AND A NECK SIZE OF 5.1 MM. THE DOME TO NECK RATIO WAS 0.7 MM AND THE PARENT VESSEL WAS 2.1 MM IN DIAMETER. THE PATIENT¿S PRE-PROCEDURE MRS SCORE WAS 2 AND HUNT & HESS GRADE WAS 2. PRE-PROCEDURE SYMPTOMS INCLUDED HEADACHE WITH PHOTOPHOBIA AND DROWSINESS. TREATMENT WAS PERFORMED ON (B)(6) 2019, WITH THE SUCCESSFULLY IMPLANTATION OF THE FOLLOWING COILS USING THE NEURON¿ MICROCATHETER (PENUMBRA) IN THE FOLLOWING ORDER: 2 MM X 4 CM GALAXY G3 MINI (GLM920040 / L13705), 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L12913), 2 MM X 4 CM GALAXY G3 MINI (GLM920040 / L12027), 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L11777) AND 3.5 MM X 7.5 CM GALAXY G3 (GLY123575 / L12491). THERE WAS NO MICROCATHETER KICKBACK AND NO INTRA-OPERATIVE THROMBOEMBOLIC EVENTS. PACKING DENSI

  Patient problems: Infarction, Cerebral

  MAUDE report 8283058 ↗