GALAXY G3 GLY120515Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10886704077510), received between Jan 25, 2018 and Sep 30, 2026 — classified as 22 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (15 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.

• MalfunctionSep 30, 2026Separation Failure; Component or Accessory Incompatibility

  A healthcare professional reported that this was a coil embolization using a GALAXY G3 5MM X 15CM Coil (product code: GLY120515, lot number: 2512562S). During coil detachment, connection to the main unit could not be made, so the device could not be detached and was removed. The reported product issue was failure to detach with connection incompatibility at the detachment interface. No patient consequences or clinical signs or symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949613 ↗
• MalfunctionFeb 12, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 5MM X 15CM GALAXY G3 (GLY120515 / 2512562S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED IN THE ANEURYSM AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A COIL FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THE PROCEDURE WAS REPORTEDLY PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 09-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE C6 SEGMENT OF THE OF THE INTERNAL CAROTID ARTERY (ICA). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT KNOWN IF THE COIL WAS STRETCHED WHEN IT WAS REMOVED. IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN. ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. THE DETACHMENT LIGHT DID NOT ILLUMINATE, AND THE AUDIBLE SIGNAL BEEP WAS NOT HEARD DURING THE DETACHMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327266 ↗
• MalfunctionSep 10, 2024Stretched; Separation Failure; Stretched; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN UNSPECIFIED MICROCATHETER (MC) WAS IN PLACE AND COIL WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE UNDER GOOD CONDITION. THE DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH, THEN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL 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 STRETCHED OR DAMAGED WHEN REMOVED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182526 ↗
• MalfunctionMar 6, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LARGE 8MM ANEURYSM LOCATED ON THE INTERNAL CAROTID ARTERY (ICA) JUST AFTER SYPHON / MEDIAL OF OPHTHALMIC ARTERY IN A YOUNG PATIENT WITH VERY TORTUOUS ANATOMY, THE ECHELON¿ 14 MICROCATHETER (MEDTRONIC) WAS PLACED INTO THE ANEURYSM BUT THE POSITION WAS NOT VERY STABLE DUE TO ANATOMY AND ANGLES, THE COILS WERE NOT DETACHABLE. THE FIRST COIL, A 7MM X 30CM MICRUSFRAME 10 (MFR100730 / 30860269) WAS CHECKED IN SALINE FOR CONFIGURATION AND CHECKED ELECTRICALLY; NO PROBLEMS WERE NOTED. THE COIL WAS PUSHED THROUGH THE MICROCATHETER WITH A LITTLE MORE RESISTANCE THAN USUALLY NOTED. THE COIL WAS THEN POSITIONED INTO THE TARGET ANEURYSM PERFECTLY. DETACHMENT DID NOT WORK. THE PHYSICIAN MADE 10 TO 12 UNSUCCESSFUL ATTEMPTS TO DETACH THE COIL. THE DETACHMENT CONTROL BOX AND THE CONTROL CABLES WERE EXCHANGED BUT THE COIL WAS STILL NOT DETACHABLE. THE BALLOON CATHETER (UNSPECIFIED BRAND) WAS INFLATED TO PROTECT AGAINST SMALL EMBOLIC COMING FROM THE ANEURYSM. THE COIL WAS REMOVED. DURING THE REMOVAL PROCESS, ELECTRIC SIGNAL WAS LOST AND AFTER COMPLETE REMOVAL, NO ELECTRICAL CONTACT WAS POSSIBLE. THE SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853237 ↗
• MalfunctionDec 13, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, AFTER A LIGHTHOUSE MICROCATHETER (MC) WAS PLACED AS PER THE INSTRUCTIONS FOR USE (IFU), COIL EMBOLIZATION WAS INITIATED. A GALAXY G3 8MM X 24CM COIL (GLY120824, 30530863) WAS INSERTED AND GOT STUCK INSIDE THE MICROCATHETER (MC). THE COIL COULD NOT BE ADVANCED, SO IT WAS RETRIEVED. THEN, REPLACED WITH ANOTHER NEW COIL WITH THE SAME SIZE, WHICH WAS IMPLANTED WITH NO ISSUES. AFTER THAT, A FEW ADDITIONAL COILS WERE IMPLANTED. A GALAXY G3 5MM X 15CM COIL (GLY120515, 30860250) WAS USED AND WOUND. ATTEMPTED TO DETACHED, BUT THE LAMP DID NOT ILLUMINATE AND COULD NOT BE DETACHED WHEN ENERGIZED. REPLACED WITH A SECOND GALAXY G3 5MM X 15CM COIL (GLY120515, LOT UNKNOWN) BUT THE LAMP CAME ON AND OFF AND WAS NOT STABLE. SINCE IT WAS UNCLEAR WHETHER THE COIL COULD BE DETACHED, THE COIL WAS RETRIEVED AND REPLACED WITH ANOTHER COIL OF A DIFFERENT SIZE AND IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED ON 08-DEC-2023 INDICATED THAT THE REPLACED COILS WERE USED SUCCESSFULLY WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319579 ↗
• MalfunctionDec 13, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, AFTER A LIGHTHOUSE MICROCATHETER (MC) WAS PLACED AS PER THE INSTRUCTIONS FOR USE (IFU), COIL EMBOLIZATION WAS INITIATED. A GALAXY G3 8MM X 24CM COIL (GLY120824, 30530863) WAS INSERTED AND GOT STUCK INSIDE THE MICROCATHETER (MC). THE COIL COULD NOT BE ADVANCED, SO IT WAS RETRIEVED. THEN, REPLACED WITH ANOTHER NEW COIL WITH THE SAME SIZE, WHICH WAS IMPLANTED WITH NO ISSUES. AFTER THAT, A FEW ADDITIONAL COILS WERE IMPLANTED. A GALAXY G3 5MM X 15CM COIL (GLY120515, 30860250) WAS USED AND WOUND. ATTEMPTED TO DETACHED, BUT THE LAMP DID NOT ILLUMINATE AND COULD NOT BE DETACHED WHEN ENERGIZED. REPLACED WITH A SECOND GALAXY G3 5MM X 15CM COIL (GLY120515, LOT UNKNOWN) BUT THE LAMP CAME ON AND OFF AND WAS NOT STABLE. SINCE IT WAS UNCLEAR WHETHER THE COIL COULD BE DETACHED, THE COIL WAS RETRIEVED AND REPLACED WITH ANOTHER COIL OF A DIFFERENT SIZE AND IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED ON 08-DEC-2023 INDICATED THAT THE REPLACED COILS WERE USED SUCCESSFULLY WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319571 ↗
• MalfunctionJun 28, 2023Failure to Advance; Separation Failure; Difficult to Advance; Failure to Advance; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY ANEURYSM, GALAXY COILS WERE USED FROM THE 8TH COIL. THE FIRST TWO COILS, A GALAXY G3 5MM X 15CM WERE PLACED WITHOUT ANY PROBLEM. THEN A GALAXY G3 5MM X 15CM (GLY120515, 30820687) WAS USED. WHEN THE COIL WAS PLACED IN THE ANEURYSM, IT WAS INVERTED T AND ATTEMPTED TO DETACH BUT COULD NOT. WHEN PRESSED THE RELEASE BUTTON ON THE CONTROL CABLE, NO RELEASE SOUND WAS HEARD. THE PHYSICIAN TRIED SEVERAL TIMES TO PUSH AND PULL THE COIL, BUT IT COULD NOT BE RELEASED. THE COIL WAS NOT DETACHED EVEN AFTER THE REPLACEMENT OF THE DATABLE BOX, THE ENPOWERCONTROLCABLE (ECB00018200, 30960241) AND THE COIL, BUT THE ISSUE CONTINUED. THEREFORE, A GALAXY G3 5MM X 15CM (GLY120515, 30817137) WAS PULLED OUT. WHEN THIS COIL OF THE SAME SIZE, WAS BEING INSERTED INTO THE PROGREAT 17 MICROCATHETER (MC), STRONG RESISTANCE WAS FELT INSIDE THE MC BEFORE THE COIL WAS INTO THE VESSEL, SO THE COIL WAS RETRIEVED. THE PROGREAT 17 MICROCATHETER WAS REPLACED WITH ANOTHER NEW PROGREAT 17. A NEW GALAXY G3 5MM X 15CM WAS ABLE TO BE INSERTED WITHOUT ANY PROBLEM. THEN TWO GALAXY G3 5MM X 15CM (GLY120515, 30666670) AND (GLY120515, 30860250) BECAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217784 ↗
• MalfunctionJun 28, 2023Failure to Advance; Separation Failure; Difficult to Advance; Failure to Advance; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY ANEURYSM, GALAXY COILS WERE USED FROM THE 8TH COIL. THE FIRST TWO COILS, A GALAXY G3 5MM X 15CM WERE PLACED WITHOUT ANY PROBLEM. THEN A GALAXY G3 5MM X 15CM (GLY120515, 30820687) WAS USED. WHEN THE COIL WAS PLACED IN THE ANEURYSM, IT WAS INVERTED T AND ATTEMPTED TO DETACH BUT COULD NOT. WHEN PRESSED THE RELEASE BUTTON ON THE CONTROL CABLE, NO RELEASE SOUND WAS HEARD. THE PHYSICIAN TRIED SEVERAL TIMES TO PUSH AND PULL THE COIL, BUT IT COULD NOT BE RELEASED. THE COIL WAS NOT DETACHED EVEN AFTER THE REPLACEMENT OF THE DATABLE BOX, THE ENPOWERCONTROLCABLE (ECB00018200, 30960241) AND THE COIL, BUT THE ISSUE CONTINUED. THEREFORE, A GALAXY G3 5MM X 15CM (GLY120515, 30817137) WAS PULLED OUT. WHEN THIS COIL OF THE SAME SIZE, WAS BEING INSERTED INTO THE PROGREAT 17 MICROCATHETER (MC), STRONG RESISTANCE WAS FELT INSIDE THE MC BEFORE THE COIL WAS INTO THE VESSEL, SO THE COIL WAS RETRIEVED. THE PROGREAT 17 MICROCATHETER WAS REPLACED WITH ANOTHER NEW PROGREAT 17. A NEW GALAXY G3 5MM X 15CM WAS ABLE TO BE INSERTED WITHOUT ANY PROBLEM. THEN TWO GALAXY G3 5MM X 15CM (GLY120515, 30666670) AND (GLY120515, 30860250) BECAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217774 ↗
• MalfunctionJun 28, 2023Failure to Advance; Separation Failure; Difficult to Advance; Failure to Advance; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY ANEURYSM, GALAXY COILS WERE USED FROM THE 8TH COIL. THE FIRST TWO COILS, A GALAXY G3 5MM X 15CM WERE PLACED WITHOUT ANY PROBLEM. THEN A GALAXY G3 5MM X 15CM (GLY120515, 30820687) WAS USED. WHEN THE COIL WAS PLACED IN THE ANEURYSM, IT WAS INVERTED T AND ATTEMPTED TO DETACH BUT COULD NOT. WHEN PRESSED THE RELEASE BUTTON ON THE CONTROL CABLE, NO RELEASE SOUND WAS HEARD. THE PHYSICIAN TRIED SEVERAL TIMES TO PUSH AND PULL THE COIL, BUT IT COULD NOT BE RELEASED. THE COIL WAS NOT DETACHED EVEN AFTER THE REPLACEMENT OF THE DATABLE BOX, THE ENPOWERCONTROLCABLE (ECB00018200, 30960241) AND THE COIL, BUT THE ISSUE CONTINUED. THEREFORE, A GALAXY G3 5MM X 15CM (GLY120515, 30817137) WAS PULLED OUT. WHEN THIS COIL OF THE SAME SIZE, WAS BEING INSERTED INTO THE PROGREAT 17 MICROCATHETER (MC), STRONG RESISTANCE WAS FELT INSIDE THE MC BEFORE THE COIL WAS INTO THE VESSEL, SO THE COIL WAS RETRIEVED. THE PROGREAT 17 MICROCATHETER WAS REPLACED WITH ANOTHER NEW PROGREAT 17. A NEW GALAXY G3 5MM X 15CM WAS ABLE TO BE INSERTED WITHOUT ANY PROBLEM. THEN TWO GALAXY G3 5MM X 15CM (GLY120515, 30666670) AND (GLY120515, 30860250) BECAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217762 ↗
• MalfunctionJun 28, 2023Failure to Advance; Separation Failure; Difficult to Advance; Failure to Advance; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY ANEURYSM, GALAXY COILS WERE USED FROM THE 8TH COIL. THE FIRST TWO COILS, A GALAXY G3 5MM X 15CM WERE PLACED WITHOUT ANY PROBLEM. THEN A GALAXY G3 5MM X 15CM (GLY120515, 30820687) WAS USED. WHEN THE COIL WAS PLACED IN THE ANEURYSM, IT WAS INVERTED T AND ATTEMPTED TO DETACH BUT COULD NOT. WHEN PRESSED THE RELEASE BUTTON ON THE CONTROL CABLE, NO RELEASE SOUND WAS HEARD. THE PHYSICIAN TRIED SEVERAL TIMES TO PUSH AND PULL THE COIL, BUT IT COULD NOT BE RELEASED. THE COIL WAS NOT DETACHED EVEN AFTER THE REPLACEMENT OF THE DATABLE BOX, THE ENPOWERCONTROLCABLE (ECB00018200, 30960241) AND THE COIL, BUT THE ISSUE CONTINUED. THEREFORE, A GALAXY G3 5MM X 15CM (GLY120515, 30817137) WAS PULLED OUT. WHEN THIS COIL OF THE SAME SIZE, WAS BEING INSERTED INTO THE PROGREAT 17 MICROCATHETER (MC), STRONG RESISTANCE WAS FELT INSIDE THE MC BEFORE THE COIL WAS INTO THE VESSEL, SO THE COIL WAS RETRIEVED. THE PROGREAT 17 MICROCATHETER WAS REPLACED WITH ANOTHER NEW PROGREAT 17. A NEW GALAXY G3 5MM X 15CM WAS ABLE TO BE INSERTED WITHOUT ANY PROBLEM. THEN TWO GALAXY G3 5MM X 15CM (GLY120515, 30666670) AND (GLY120515, 30860250) BECAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217743 ↗
• MalfunctionJun 21, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF POST PROCEDURAL GASTROINTESTINAL BLEEDING, A GALAXY G3 5MM X 15CM COIL (GLY120515, 30719534) WAS PREPARED AS USUAL WITH PERFORMING CONTINUOUS FLUSH. AFTER SEVERAL COILS WERE IMPLANTED, THE LAST ONE COULD NOT BE DETACHED. CABLE WAS REPLACED BUT THE ISSUE CONTINUED. THE LAST GALAXY G3 COIL WAS PULLED INTO THE MICROCATHETER, AND THE MICROCATHETER AND THE COIL WERE WITHDRAWN AS A UNIT BECAUSE THE COIL COULD BE DETACHED DURING RETRIEVAL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE PROWLER SELECT PLUS MICROCATHETER, OKAY Y CONNECTOR, EMPOWER CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170415 ↗
• InjuryJun 14, 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 60-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING (CURRENT SMOKER) UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION BRANCH ANEURYSM WITH A HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON 10-NOV-2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.4MM, DOME 10.5MM, MAXIMUM ANEURYSM DIAMETER 10.5MM, NECK SIZE 4.9MM, AND DOME-TO-NECK RATIO OF 2.1MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: AN 11MM X 18.9CM MICRUSFRAME 18 (MFR181118 / 30422246), A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30537019), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / 30379819), A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30624675), AND A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30789543) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE PRINCIPAL INVESTIGATOR (PI), THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE; THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYM

  Patient problems: Aneurysm

  MAUDE report 17131999 ↗
• MalfunctionMar 22, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A BASILAR ARTERY ANEURYSM, THE PHYSICIAN USED THE DOUBLE CATHETER TECHNIQUE. A GALAXY G3 5MM X 15CM COIL (GLY120515, 30747558) WAS INSERTED INTO A MICROCATHETER (GREACH, TOKAI MEDICAL PRODUCTS) AND ADVANCED THROUGH THE MICROCATHETER (MC) BUT BECAME STUCK ON THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED FROM THE MICROCATHETER AND UNRAVELING WAS CONFIRMED. THIS ISSUE OCCURRED BEFORE THE COMPLAINT COIL WAS INSERTED INTO THE PATIENT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NOTHING WAS OBSTRUCTING THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590771 ↗
• 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 19-SEP-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 15936912 ↗
• 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 15936883 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT (B)(6)), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208/30

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759678 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT 00971-020), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON 15-MAR-2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759603 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT (B)(6), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208/305

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759595 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714075 ↗
• MalfunctionJun 10, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, PRIOR TO STENT GRAFT, THIS WAS AN EMBOLIZATION OF THE SUPERIOR GLUTEAL, INFERIOR GLUTEAL, ILIOPSOAS ARTERY AT THE LEFT INTERNAL ILIAC ANEURYSM AND OTHER BRANCHES WERE PERFORMED IN ADVANCE. A CONCOMITANT MICROCATHETER (BREAKTHROUGH, BOSTON SCIENTIFIC) WAS ACCESSED TO EMBOLIC SITE VIA CONTRALATERAL A SHEPHARD HOOK. A 5MM X 15CM GALAXY G3 (GLY120515, 30729913) WAS USED AS THE 25TH COIL. WHEN STACKING THE UPPER AND LOWER BUTTOCKS, THERE WAS A STRONG RESISTANCE WITH THE COIL IN THE BREAKTHROUGH (BOSTON SCIENTIFIC) MICROCATHETER (MC), AND EVEN WHEN THE WIRE WAS PULLED BACK, THE COIL DID NOT COME BACK, THEREFORE IT WAS JUDGED TO BE UNRAVELED. THE COMPLAINT COIL WAS REMOVED WITH THE MICROCATHETER TOGETHER FROM THE PATIENT¿S BODY. THEN A 16MM X 47CM MICRUSFRAME18 COIL (MFR181647, 30729925) WAS USED AS THE 29TH COIL. THIS COIL WAS TO BE PLACED IN A LARGER SPACE IN THE UPPER AND LOWER HOUSES, BUT THERE WAS A RESISTANCE FELT IN THE MC, THEREFORE, THE COIL WAS CHANGED TO ANOTHER ONE. WHEN USING A GALAXY G3 WITH A SMALL DIAMETER ONCE, IT ENTERED SMOOTHLY AND IMPLANTED SAFELY. AT THE END OF THE PROCESS, A 4MM X 10CM GALAXY G3 COIL (GLY120410, 30663175) WAS USED AS THE 37

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655678 ↗
• 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 14270019 ↗
• 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 14078829 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APPROAC

  Patient problems: Ischemia Stroke

  MAUDE report 13497536 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APPROACH

  Patient problems: Ischemia Stroke

  MAUDE report 13497486 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APPROACH

  Patient problems: Ischemia Stroke

  MAUDE report 13497430 ↗