Axium Prime Detachable Coil System APB-1-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000313616), received between Nov 22, 2021 and Jun 19, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 reports).

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

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM LOCATED ON THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY, WITH A MAX DIAMETER OF 4MM AND A 1.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT INTRAOPERATIVELY, THE COIL BECAME STRETCHED; ANOTHER COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALL DEVICES WERE PREPARED AS INDICATED IN THE IFU AND NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. NO ISSUES WERE IDENTIFIED THAT RESULTED IN THE DAMAGE OBSERVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED AND REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562426 ↗
• MalfunctionMay 29, 2026Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON APRIL 27, A PATIENT WITH AN INTRACRANIAL C7 ANEURYSM WAS TREATED. AFTER COMPLETION OF DIAGNOSTIC ANGIOGRAPHY, ACCESS WAS ESTABLISHED USING A 6F INTRACRANIAL SUPPORT CATHETER, A 27 MICROCATHETER, AND AN ECHELON MICROCATHETER. AFTER THE 27 STENT CATHETER AND THE ECHELON MICROCATHETER WERE POSITIONED, A PED-375-20 WAS ADVANCED AND PARTIALLY DEPLOYED. A PRIME 3D 1-4 COIL WAS THEN PLACED INTO THE ECHELON MICROCATHETER, BUT AFTER THE COIL WAS DELIVERED INTO THE MICROCATHETER, IT COULD NOT COME OUT. SUBSEQUENTLY, A PRIME 3D 1-2 COIL WAS OPENED INSTEAD, WHICH ALSO COULD NOT BE ADVANCED INTO THE ECHELON MICROCATHETER. SUSPECTING AN ISSUE WITH THE MICROCATHETER, IT WAS REPLACED WITH ANOTHER ECHELON MICROCATHETER (105-5091-150). THE PRIME 3D 1-4 COIL WAS THEN SUCCESSFULLY ADVANCED THROUGH THE MICROCATHETER AND USED TO EMBOLIZE THE ANEURYSM; HOWEVER, DETACHMENT WAS UNSUCCESSFUL AFTER TWO ATTEMPTS. THE COIL WAS SUBSEQUENTLY REPLACED WITH A PRIME 3D 1-2, WHICH ALSO COULD NOT BE DETACHED. AFTER REPLACING IT AGAIN WITH ANOTHER PRIME 3D 1-2 COIL, EMBOLIZATION AND DETACHMENT WERE SUCCESSFUL. THE FLOW-DIVERTING STENT WAS DEPLOYED AT THE SAME TIME, THE PROCEDURE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340778 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT AFTER PREMATURE DETACHMENT, THE TAIL END OF THE COIL FLOATED IN THE VESSEL. A STENT WAS USED TO PIN IT AGAINST THE VESSEL WALL. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. AN INTERVENTIONAL EMBOLIZATION PROCEDURE FOR A POSTERIOR COMMUNICATING ARTERY ANEURYSM WAS PLANNED. THE SURGEON SELECTED THE ECHELON-10 MICROCATHETER FOR THE PROCEDURE. THE FIRST COIL USED FOR EMBOLIZATION WAS A QC-3-8-3D COIL. THE SECOND COIL FILLED FOR EMBOLIZATION WAS A WEIXIN 2*6 COIL. THE THIRD COIL SELECTED FOR EMBOLIZATION WAS AN APB-1-2-3D-ES COIL. DURING THE EMBOLIZATION PROCESS, THE COIL DETACHED PREMATURELY AND AUTOMATICALLY. THE FOURTH COIL TO BE FILLED WAS AN APB-1.5-4-HX-ES, AND THE FIFTH ITEM TO BE FILLED WAS A WEIXIN 1.52 COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513546 ↗
• MalfunctionOct 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGICAL PREPARATION WITH THE AXIUM PRIME BARE 3D 1MM X 2CM EXTRA SOFT, THE SPRING COIL COULD NOT BE PUSHED OUT, THERE WAS RESISTANCE WITH THE COIL, AND THE COIL BECAME STUCK IN THE SHEATH. THE DEVICE WAS NEVER IMPLANTED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PATIENT WAS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427398 ↗
• MalfunctionOct 29, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE 3D COIL PUSHER WAS OBSERVED TO BE KINKED UPON OPENING. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. WHEN THE COIL PACKAGE WAS OPENED, IT WAS FOUND THAT THE SPRING COIL PUSH ROD WAS KINKED. IN VITRO EXAMINATION REVEALED THAT THE SPRING COIL WAS DAMAGED, SO ANOTHER PRODUCT OF THE SAME MODEL WAS USED TO CONTINUE THE SURGERY. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. IT WAS NOT CONFIRMED IF ANY PREPARATION WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WERE NO ISSUES THAT RESULTED IN THE DEVICE DAMAGE THAT WAS FOUND. THE CAUSE OF THE KINK WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413949 ↗
• MalfunctionJul 30, 2025Stretched; Stretched

  MEDTRONIC RECEIVED REPORT THAT DURING THE DELIVERY OF THE AXIUM COIL, IT WAS NOTED THAT THE TIP OF THE COIL WAS STRETCHED. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES HAD BEEN PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REMOVED AND REPLACED TO CONTINUE TO THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A C6 SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3.2MM AND THE NECK WAS 3.1MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO ISSUES RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669021 ↗
• MalfunctionJul 23, 2025Stretched; Stretched

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577936 ↗
• MalfunctionJun 26, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STRETCHED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4 MM AND NECK DIAMETER 2 MM. THE PATIENT¿S VESSEL TORTUOSITY AND BLOOD FLOW WAS NORMAL. THE SURGEON SELECTED APB-1-2-3D-ES EMBOLIZATION. THE SPRING COIL WAS STRETCHED DURING THE OPERATION, AND THE SURGEON REQUESTED A REPLACEMENT AND RETAINED THE SAMPLE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE COIL STRETCH WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341240 ↗
• MalfunctionJun 23, 2025Incomplete or Missing Packaging; Detachment of Device or Device Component; Incomplete or Missing Packaging; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE PUSHWIRE SEPARATION WAS THE PART WITHOUT IMPLANTED COIL. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING, THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312380 ↗
• MalfunctionApr 28, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE COIL RESISTANCE/TEAR WAS NOT DETERMINED. THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DETACHMENT ATTEMPTS WERE MADE, AND NO KINK/DAMAGE WAS OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918787 ↗
• MalfunctionFeb 12, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, A DETACHABLE SPRING COIL, SPECIFICALLY THE AXIUM PRIME BARE 3D 1MM X 2CM EXTRA SOFT, ENCOUNTERED RESISTANCE AND BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 6MM AND A NECK DIAMETER OF 3MM, WITH NORMAL BLOOD FLOW AND MINIMAL VESSEL TORTUOSITY. THE COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. THE SURGEON ATTEMPTED TO USE ANOTHER COIL OF THE SAME TYPE, WHICH FUNCTIONED NORMALLY. THE INITIAL COIL WAS WITHDRAWN, AND THE SAMPLE WAS RETAINED. THE SURGEON REQUESTED THAT NO FEES BE CHARGED FOR THE MALFUNCTIONING COIL. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY; THE RESISTANCE WAS RELATIVELY LARGE. THERE WAS A KINK OBSERVED TO THE COIL AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364795 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE PREMATURE DETACHMENT. THERE WAS NO KIN K/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079625 ↗
• MalfunctionOct 2, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE IN THE CATHETER AND WERE STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR INTRACRANIAL ANEURYSM IN THE LEFT HEMISPHERE. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL WAS BEING USED IN THE FINAL STAGE AFTER OTHER COILS HAD BEEN SUCCESSFULLY DELIVERED. RESISTANCE WAS FELT DURING DELIVERY OF THE COIL IN THE MICROCATHETER SO IT WAS PULLED OUT. COIL STRETCH AND WIRE DRAWING WAS OBSERVED. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME MODEL/LOT AND THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED AGAIN TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE RESISTANCE WAS LOCATED IN THE MIDDLE SECTION OF THE CATHETER. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THE CONTINUOUS CATHETER FLUSH WAS ADMINISTERED PER IFU DURING THE PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353536 ↗
• MalfunctionOct 2, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE IN THE CATHETER AND WERE STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR INTRACRANIAL ANEURYSM IN THE LEFT HEMISPHERE. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL WAS BEING USED IN THE FINAL STAGE AFTER OTHER COILS HAD BEEN SUCCESSFULLY DELIVERED. RESISTANCE WAS FELT DURING DELIVERY OF THE COIL IN THE MICROCATHETER SO IT WAS PULLED OUT. COIL STRETCH AND WIRE DRAWING WAS OBSERVED. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME MODEL/LOT AND THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED AGAIN TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE RESISTANCE WAS LOCATED IN THE MIDDLE SECTION OF THE CATHETER. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THE CONTINUOUS CATHETER FLUSH WAS ADMINISTERED PER IFU DURING THE PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353481 ↗
• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL AND ECHELON CATHETER ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT VERTEBRAL ARTERY WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THERE WAS RESISTANCE AT THE DISTAL END OF THE CATHETER AND THE COIL COULDN'T PASS THROUGH IT. IT WAS REPORTED THE AXIUM SPRING COIL WAS STUCK AT THE TIP OF THE MICROCATHETER AND COULDN'T BE PUSHED OUT. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK AT CATHETER HUB. THERE WAS CATHETER DAMAGE IN THE DISTAL SECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906830 ↗
• MalfunctionMar 3, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED, CLARIFIED THAT THE COIL ONLY PREMATURELY DETACHED, AND DID NOT SEPARATE/FRACTURE. THE COIL HAD EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER. THERE WAS NO KINK/DAMAGE OBSERVED, TO THE COIL. THE CATHETER USED WAS NOT MANUFACTURED BY MEDTRONIC. AND NO DETACHMENT ATTEMPTS HAD BEEN MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478043 ↗
• MalfunctionJul 19, 2022Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL EXPERIENCED RESISTANCE AND DETACHED INSIDE THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE AOM. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 1.2MM. THE PATIENT'S BLOOD FLOW WAS HIGH, AND THEIR VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT COIL WAS STUCK IN THE DISTAL PORTION OF THE MICROCATHETER. THE PHYSICIAN THEN CAREFULLY REMOVED THE SYSTEM, AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. IT WAS NOTED THAT THE PUSHWIRE WAS BENT/BROKEN. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053860 ↗
• MalfunctionJun 30, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL COULD NOT BE DETACHED IN VIVO. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE LEFT OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14866502 ↗
• MalfunctionNov 22, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE DETACHMENT ATTEMPT WAS MADE WITH THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE WITH THE MANUAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852636 ↗