GALAXY G3 GLX120306Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10886704077695), received between Jun 16, 2017 and Dec 2, 2025 — classified as 16 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Stretched” (13 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 XSFT 3MM X 6CM (GLX120306/ 1042541S) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED RESISTANCE/FRICTION-DURING ADVANCING THE COIL THROUGH AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING 3X6 COIL THROUGH EXCELSIOR SL-10 M/C.¿ THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 25-SEP-2025. SUMMARY: REGARDING WHETHER THE EVENT RESULTED IN A PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS REPORTED ¿THE PROCEDURE WAS DELAYED. (M/C RE-SELECTION & COILING).¿ RESISTANCE WAS FIRST ENCOUNTERED DURING DEVICE ADVANCEMENT. REGARDING WHERE THE RESISTANCE WAS FELT, IT WAS REPORTED ¿THE COIL FAILED TO ENTER THROUGH M/C. PLEASE CHECK THE INSIDE OF THE CATHETER. IT IS SAID THAT THE COIL PRODUCT IS BROKEN. COIL CUT OFF).¿ REGARDING WHETHER OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE, IT WAS REPORTED, ¿SEVERAL COILS USED (G3 COIL & TETRA COIL) USED 5TH TIME.¿ REGARDING WHETHER IT WAS NECESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696298 ↗
• MalfunctionNov 20, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 0842515S) FILLED THE TARGET ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH ANOTHER COIL OF A DIFFERENT BRAND TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 18-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS STRETCHED WHEN IT WAS REMOVED, BUT IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE PROCEDURE. UPON PRESSING THE POWER BUTTON, THE DETACHMENT LIGHT DID NOT ILLUMINATE, AND THE AUDIBLE SIGNAL BEEP WAS NOT HEARD. ALL CONNECTIONS FIT WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607617 ↗
• MalfunctionJun 13, 2025Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON 30-MAY-2025, DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE INTERNAL CAROTID ARTERY, THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE PROCEDURE WAS INITIATED AFTER THE TARGET WAS APPROACHED WITH THE EMBOGUARD BALLOON CATHETER, THE GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL), AND THE GREACH® MICROCATHETER (TOKAI MEDICAL), WHEN THE SECOND 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 31073013) WAS DELIVERED IN THE MICROCATHETER, STRONG RESISTANCE WAS FELT. DURING THE REMOVAL OF THE 3MM X 6CM GALAXY G3 XSFT COIL, IT BECAME UNRAVELED. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER AS A WHOLE SYSTEM; IT WAS VERIFIED NOTHING REMAINED IN THE PATIENT¿S BODY. THE COIL WAS REPLACED WITH ANOTHER 3MM X 6CM GALAXY G3 XSFT (GLX120306), WHICH WAS USED WITHOUT RESISTANCE AFTER THE GREACH MICROCATHETER WAS FLUSHED. A TOTAL OF FIVE (5) GALAXY G3 COILS WERE USED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE EMBOLIZATION PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 10-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203951 ↗
• MalfunctionJan 7, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30789562) WAS USED AND FILLED IN THE ANEURYSM. THE SYSTEM READY LIGHT DID NOT ILLUMINATE WHEN THE COIL SYSTEM CONNECTED VIA THE CONTROL CABLE (CCB) TO THE DETACHMENT CONTROL BOX (DCB). THE PHYSICIAN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN REPLACED THE CCB, BUT THE COIL STILL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A NEW COIL, AND THE SYSTEM READY LIGHT OF THE REPLACEMENT COIL ILLUMINATED NORMALLY, THEN COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED COMPETITOR BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A SHORT MP4 VIDEO CLIP WAS INCLUDED IN THE COMPLAINT. THE CLIP WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM. ON 06-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED, THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093782 ↗
• MalfunctionSep 9, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN JUST STARTED TO FILL THE ANEURYSM WITH A GALAXY G3 XSFT 3MM X 6CM COIL (GLX120306, 30772779), IT WAS FOUND THAT THE FILLING SITE WAS UNSATISFACTORY. THEREFORE, THE PHYSICIAN RETRACTED THE COIL, BUT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL OUT OF THE PATIENT AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE UNSPECIFIED MICROCATHETER (MC) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20175545 ↗
• MalfunctionJul 23, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30393369) DID NOT SLIDE INTO THE CATHETER WITH TOO MUCH FRICTION AND DID NOT GO INTO THE MICROCATHETER. THE ISSUE OCCURRED BEFORE THE DEVICE WAS USED IN THE PATIENT. ¿ANOTHER COIL WAS USED PERFECTLY WITH NO FRICTION NOTICED.¿ THERE WAS NO NEGATIVE PATIENT IMPACT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 23-JUL-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812955 ↗
• MalfunctionApr 15, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FILLED THE ANEURYSM WITH THE FIRST COIL, A GALAXY G3 XSFT 3MM X 6CM (GLX120306, 30772779). IT WAS FOUND THAT THE COIL BECAME UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-APR-2024 INDICATED THAT PRIOR TO THIS COIL, OTHER COILS HAD BEEN ABLE TO BE ADVANCED THROUGH THE SAME MICROCATHETER. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE COIL DID NOT BECOME ENTANGLED WITH OTHER IMPLANTED COILS. THE COIL DID NOT STRETCH AND THEN BREAK IN TWO PIECES WITH ATTEMPT TO REMOVE FROM THE PATIENT OR ANEURYSM. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19108106 ↗
• MalfunctionMar 11, 2024Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 3MM X 6CM COIL (GLX120306, 30789546) WAS CUT DURING DEPLOYMENT INSIDE THE ANEURYSM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875933 ↗
• MalfunctionMar 8, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS TARGETING AN ANEURYSM ON THE INTERNAL CAROTID ARTERY (ICA), THE ISSUE WAS NOTED PRIOR TO THE USE OF THE COMPLAINT DEVICE, A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30817123), WHICH WAS SELECTED TO BE THE FRAMING COIL; THE COIL WAS OBSERVED TO BE UNRAVELED. IT WAS NOT USED IN THE PATIENT. A REPLACEMENT COIL WAS USED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 21-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, THE BRAND AND SIZE OF THE MICROCATHETER USED COULD NOT BE OBTAINED. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ON 08-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL BESIDE THE REPORTED UNRAVELED STATE. THE REPLACEMENT COIL WAS NOT ANOTHER 3MM X 6CM GALAXY G3 XSFT (GLX120306).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867037 ↗
• MalfunctionJan 18, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A RUPTURED CEREBRAL ANEURYSM, PRIOR TO INSERTING THE COIL, A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30747540), AN ELECTRICAL CHECK WAS PERFORMED AND NO PROBLEM WAS FOUND. AFTER INSERTION OF THE COIL INTO THE ANEURYSM, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT IT WAS REPORTED THAT IT COULD NOT BE DETACHED ¿EVEN AFTER ENERGIZING.¿ THE CONCOMITANT ENPOWER CONTROL CABLE (ECB00018200 / 31000822) WAS REPLACED, BUT THE COIL WAS STILL NOT ABLE TO BE DETACHED. THE COIL WAS RETRIEVED. THE PROCEDURE WAS REPORTEDLY SUCCESSFULLY COMPLETED; THERE WAS NO NEGATIVE PATIENT IMPACT. ON 11-JAN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540064 ↗
• MalfunctionNov 6, 2023Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANEURYSM AT THE INTERNAL CAROTID ARTERY - POSTERIOR COMMUNICATING ARTERY BIFURCATION, A GALAXY G3 XSFT 3MM X 6CM COIL (GLX120306, 30686605) WAS ATTEMPTED TO BE IMPLANTED AS A SECOND COIL, BUT DUE TO EARLY DETACHMENT, THE COIL WAS NOT IMPLANTED AND WAS REMOVED TOGETHER WITH THE UNSPECIFIED MICROCATHETER (MC). THE MC WAS REPLACED. AFTER THAT, THE COMPETITOR'S TARGET 3-6 WAS IMPLANTED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. AS A FIRST COIL, A G3 XSFT XSFT 3.5-7.5 WAS IMPLANTED FOR THE ANEURYSM. ADDITIONAL INFORMATION RECEIVED ON 02-NOV-2023 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE COIL DETACHED FROM THE DETACHMENT ZONE. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074374 ↗
• 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 16369029 ↗
• 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 02-NOV-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 16369000 ↗
• 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 / L1555

  Patient problems: Aneurysm; Hydrocephalus

  MAUDE report 16368999 ↗
• InjuryJan 17, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A 54-YEAR-OLD FEMALE (SUBJECT (B)(6) WITH NO TARGETED MEDICAL HISTORY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2022. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE SCORE WAS 0 AND THE HUNT & HESS GRADE WAS 2 - MODERATE TO SEVERE HEADACHE, NUCHAL RIGIDITY, AND NO NEUROLOGIC DEFICIT OTHER THAN CRANIAL NERVE PALSY. THE DIMENSIONS OF THE ANTERIOR CEREBRAL ARTERY ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT OF 8.5 MM, DOME 8.1 MM, MAXIMUM ANEURYSM DIAMETER OF 8.1 MM, NECK SIZE OF 2.6 MM, AND THE DOME-TO-NECK RATIO OF 3.1 MM. THE PARENT VESSEL DIAMETER WAS 1.7 MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH FOUR (4) CERENOVUS COILS VIA AN SL-10 MICROCATHETER (STRYKER). THE COILS WERE THE FOLLOWING: ONE 8MM X 13.6MM MICRUSFRAME S (MFR180813/K10699), ONE 6 MM X 15 CM GALAXY G3 (GLY120615/K10390), ONE 4 MM X 12 CM GALAXY G3 (GLY120412/30637578), AND ONE GALAXY G3 XTRASOFT (GLX120306/30603573). HEPARIN WAS ADMINISTERED. THE SUBJECT DID NOT EXPERIENCE INTRA-OPERATIVE RUPTURE OR THROMBOEMBOLIC EVENTS. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COM

  Patient problems: Aneurysm

  MAUDE report 16187143 ↗
• 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 15987132 ↗
• 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 2.5MM

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987107 ↗
• MalfunctionDec 5, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED AT THE LEFT GASTRIC ARTERY, THE PARENT CATHETER(S) ACCESSED THE CELIAC AND A PROGREAT® MICROCATHETER (TERUMO) ACCESSED THE TARGET LESION. INTERLOCK(S) AND PUSHABLE COIL(S) EMBOLIZED THE LESION, AND ¿DETACHABLE WAS USED FOR THE PROXIMAL REGION AS WELL.¿ A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410) WAS WINDED AND IMPLANTED. AFTER THAT, THE SAME SIZE COIL(S) WERE USED. HOWEVER, WHEN ONE OF THE COMPLAINT COILS, A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30624682) WAS USED, THERE WAS RESISTANCE FELT INSIDE THE MICROCATHETER AND ¿WINDING WAS IMPOSSIBLE.¿ THE COMPLAINT COIL WAS RESHEATHED, BUT IT BECAME UNRAVELED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REPLACED AND THE COIL WAS REPLACED WITH A 3MM X 6CM GALAXY G3 XSFT COIL (GLX120306 / 30747539), BUT THE REPLACEMENT COIL ALSO BECAME UNRAVELED INSIDE THE REPLACEMENT MICROCATHETER. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. THE MICROCATHETER WAS REPLACED AND COMPETITOR COIL(S) WERE USED. THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 04-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916240 ↗
• 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 (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 USED. ALL CO

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714105 ↗
• MalfunctionSep 8, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3MM X 6CM GALAXY G3 COIL (GLX120306, 30624678) WAS USED AS THE SECOND COIL. HOWEVER, 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 THAT THE COIL WAS STRETCHED. THE PHYSICIAN USED THE SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378453 ↗
• MalfunctionAug 25, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, THE PROCEDURE WAS FOR A TYPE 2 ENDOLEAK (EL), 3MM X 6CM GALAXY G3 COIL (GLX120306, 30727836) WAS INSERTED BY THE COAXIAL TECHNIQUE WITH USING A CATHETER (LEONIS MOVA HF) AND A CONCOMITANT MICROCATHETER (1.9 FR, CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS). THE LESION WAS REACHED WITH THE BEFOREMENTIONED SYSTEM. COIL PREPARATION WAS NOT A PROBLEM. AS THE PHYSICIAN DID NOT HOLD THE CARNELIAN MARVEL DURING COIL PLACEMENT, ONLY THE CATHETER WAS PULLED BACK LARGELY. THE PHYSICIAN ATTEMPTED TO MOVE THE CARNELIAN MARVEL BACK IN POSITION BY ADVANCING THE CATHETER ALONG THE COIL WIRE. HOWEVER, THE CATHETER GOT STUCK AND WAS NOT ABLE TO ADVANCE FORWARD. THE COIL WAS REMOVED WITH THE CONCOMITANT MICROCATHETER FROM THE PATIENT¿S BODY. THE COIL AND THE MICROCATHETER WERE REPLACED WITH EACH NEW PRODUCT. THE PROCEDURE WAS COMPLETED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THERE WAS NO PARTICULAR PROBLEM DETECTED WITH THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS LUMBAR ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING NOTED OBSTRUCTING THE MICROCATHETER. NO EXCESSIVE FORCE WAS AP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294478 ↗
• MalfunctionAug 24, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN INTERNAL CAROTID POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM, THE COMPLAINT COIL, A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30550290) WAS USED, BUT THERE WAS RESISTANCE AND THE COIL GOT STUCK INSIDE THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE COMPLAINT COIL WAS PUSHED WITH FORCE, BUT IT WAS ABLE TO ADVANCE THROUGH THE MICROCATHETER. A CONTINUOUS FLUSH WAS REPORTEDLY MAINTAINED THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS RE-SHEATHED AND THE PHYSICIAN NOTICED THAT THE EMBOLIC COIL COMPONENT HAD UNRAVELED. IT WAS REMOVED TOGETHER WITH THE MICROCATHETER AND THE PROCEDURE WAS RESTARTED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT DUE TO THE REPORTED ISSUE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288670 ↗
• MalfunctionMay 7, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM GALAXY G3 XSFT COIL (GLX120306 / 30498780). BECAME STRETCHED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319233 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM AND EXPERIENCED INTRAOPERATIVE ANEURYSM RUPTURE. DETAILS OF THE PROCEDURE: A 6F SHUTTLE SHEATH WAS INSERTED VIA THE FEMORAL ARTERY AND DELIVERED TO THE VERTEBRAL ARTERY (VA). A 6F SOFIA PLUS CATHETER (MICROVENTION) WAS THEN DELIVERED TO THE PROXIMAL BASILAR ARTERY AS A DISTAL ACCESS CATHETER (DAC). THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANRD (211D/3056488803) WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER (606S255X/30250996), BUT TORQUE WAS NOT APPLIED WELL. THE PULSE RIDER DIRECTION WAS NOT PROPER, AND THE DIRECTION WAS ADJUSTED BY APPLYING TORQUE WHILE RETRACTING THE DEVICE INTO THE PROWLER SELECT PLUS MICROCATHETER. THIS WAS ATTEMPTED THREE TIMES, BUT THE ORIENTATION DID NOT CHANGE. THE PHYSICIAN REMOVED THE PULSERIDER FROM THE PATIENT ONCE AND REINSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER. THE PROWLER SELECT PLUS WAS REPLACED WITH A HEADWAY 27 MICROCATHETER (MICROVENTION) BECAUSE THE COMPLAINT MICROCATHETER DID NOT ORIENT IN THE SAME WAY WHEN DEPLOYED AND DID NOT CHANGE EVEN WHEN TORQU

  Patient problems: Aneurysm

  MAUDE report 14270035 ↗
• 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 14078921 ↗