Axium Prime Detachable Coil System APB-1-1-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000313784), received between Mar 1, 2022 and Mar 31, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER THE ECHELON-10 MICROCATHETER WAS POSITIONED BY THE OPERATOR, COIL EMBOLIZATION WAS PERFORMED. DURING FILLING OF THE APB-1-1-HX-ES COIL, IT WAS FOUND TO BE DIFFICULT TO ADJUST THE COIL. AFTER WITHDRAWING THE COIL FROM THE PATIENT'S BODY, IT WAS FOUND THAT THE COIL HAD LOST ITS ORIGINAL SHAPE AND HAD STRETCHED PREMATURELY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT THE SPRING COIL DID NOT DETACH PREMATURELY; ONLY A PORTION OF THE COIL STRETCHED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS NOTED THAT THE SURGEON USED THE DEVICE NORMALLY FOR FILLING, AND NO OTHER PROBLEMS WERE FOUND. THERE WERE NO DETACHMENT ATTEMPTS MADE. THERE WAS NO KINK/DAMAGE OBSERVED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746427 ↗
• MalfunctionFeb 4, 2026Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Inadequacy of Device Shape and/or Size; Stretched; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT ONE AXIUM COIL WAS STRETCHED DURING THE EMBOLIZATION PROCEDURE, AND ANOTHER AXIUM COIL BECAME BENT DURING DELIVERY AND COULD NOT BE USED. THE COIL EXPERIENCED UNEXPECTED BENDING, LOSS OF FLEXIBILITY, AND LOSS OF SHAPEABILITY EITHER WITHIN THE MICROCATHETER OR AT THE MOMENT OF EXITING THE MICROCATHETER. AS A RESULT, IT COULD NOT BE SMOOTHLY FILLED INTO THE ANEURYSM CAVITY AND POSED AN OPERATIONAL RISK. ULTIMATELY, THIS COIL HAD TO BE ABANDONED. THEREPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL (APB-1-1-HX-ES) WAS IMPLANTED AND THE LOCATION WAS NOT IDEAL. THE PROCEDURE WAS COMPLETED BY PUSHING THE STRETCHED PORTION INTO THE TUMOR CAVITY USING A MICROCATHETER. THE CAUSE OF THE COIL DAMAGE/SHAPE ISSUE 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 24256819 ↗
• MalfunctionDec 22, 2025Break; Separation Failure; Unintended Movement; Migration; Break; Separation Failure; Unintended Movement; Migration

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PROCEDURE WAS COMPLETED AFTER DETACHMENT OF THE COIL. THE COIL THAT MIGRATED DISTALLY COULD NOT BE RETRIEVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23872160 ↗
• MalfunctionDec 1, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. THE INSTANT DETACHER WAS NOT USED. PRIOR TO THE COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680241 ↗
• MalfunctionOct 30, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE BASILAR ARTERY APEX WITH A MAX DIAMETER OF 5 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN DETACHING THE AXIUM COIL, THE PUSH ROD WAS BROKEN MANUALLY, BUT THE SPRING COIL DID NOT DETACH. THE PHYSICIAN DID NOT TRY TO DETACH WITH AN INSTANT DETACHER. THERE WERE 2 MANUAL ATTEMPTS TO DETACH VIA HYPOTUBE. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, NO OTHER ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426875 ↗
• MalfunctionOct 25, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS TREATED FOR AN ANEURYSM EMBOLIZATION. WHEN THE COIL WAS BEING DELIVERED THROUGH THE MICROCATHETER, NO COIL WAS VISIBLE AT THE TIP. UPON REMOVAL FROM THE BODY, NO COIL WAS FOUND AT THE TIP, ONLY THE PUSH ROD. NO COIL WAS FOUND IN THE PACKAGING, SO THE COIL WAS REPLACED AND A DEFECTIVE PRODUCT COMPLAINT WAS FILED. IT WAS BELIEVED THAT THE SPRING COIL WAS NOT ASSEMBLED BEFORE THE PRODUCT WAS SHIPPED. THE COIL WAS NOT FOUND IN THE PACKAGING. THE REPORT THAT "NO COIL WAS VISIBLE AT THE TIP" WAS CLARIFIED TO MEAN THAT THERE WAS NO SPRING COIL AT THE TIP END OF THE PUSH ROD. THERE WAS NO PREMATURE DETACHMENT. THERE WAS NO SEPARATION. THERE WERE NO DETACHMENT ATTEMPT. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS NOT IMPLANTED IN THE PATIENT. THE CATHETER WAS A HEADWAY17, NON-MEDTRONIC PRODUCT. 3 COILS WERE IMPLANTED BEFORE AND AFTER THIS MALFUNCTIONED COIL. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386919 ↗
• MalfunctionJul 3, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS ON THE OPERATING TABLE WITH AN INTERNAL CAROTID C6 SEGMENT ANEURYSM. THE MICROGUIDE WIRE LED THE ECHELON10 MICROCATHETER INTO THE ANEURYSM, AND 1.5-2-3D, 1-1-HX WERE FILLED IN SEQUENCE. AFTER THE 1-1 SPRING COIL WAS OPENED, THE PUSH ROD WAS KINKED. THE SURGEON TRIED TO FILL THE 1-1 SPRING COIL INTO THE ANEURYSM AND FOUND THAT THE SPRING COIL WAS DIFFICULT TO PUSH OUT IN THE MICROCATHETER. CONSIDERING THE SAFETY OF THE SURGERY, REPLACED IT WITH A NEW 1-1 SPRING COIL AND IMPLANTED. THERE WAS NO ABNORMALITY IN THE ANGIOGRAPHY, AND THE SURGERY WAS OVER. THERE WAS PUSHER KINK/BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 2.9 MM AND A 2.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397326 ↗
• MalfunctionJun 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE ENCOUNTERED RESISTANCE IN THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM (INTRACRANIAL ANEURYSM) WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4 MM AND NECK DIAMETER 3 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (7 MM DIAMETER). THE FIRST MICROCATHETER WAS FOUND TO BE LEAKING DURING HYDRATION, SO IT WAS REPLACED WITH THE SECOND MICROCATHETER. DURING THE PROCESS OF FILLING THE SPRING COIL, IT HAD GREAT RESISTANCE TO PUSHING THE SPRING COIL AT THE TIP OF THE MICROCATHETER. AFTER REPEATED ATTEMPTS, IT STILL COULD NOT BE DELIVERED INTO THE ANEURYSM. THIS COIL WAS THE LAST ONE, SO IT WAS REMOVED FROM THE BODY AND THE OPERATION WAS ENDED. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT RECOVERED NORMALLY AFTER SURGERY. THE SECOND ECHELON USED WAS AN ECHELON 10, BUT THE LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341286 ↗
• MalfunctionJun 18, 2025Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE CATHETER RESISTANCE WAS NOT DETERMINED. REGARDING THE CAUSE OF THE THREE USED COILS RESISTANCE AND CATHETER DAMAGE, THE SURGEON CONSIDERED IT TO BE A PROBLEM WITH THE QUALITY OF THE MICROCATHETER. THE COIL DAMAGE MAY HAVE BEEN CAUSED BY THE RESISTANCE OF THE MICROCATHETER DURING DELIVERY. THE CATHETER DAMAGE OBSERVED WAS KINKING. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE COIL DAMAGE OBSERVED WAS A BREAKAGE. THE COIL APB-1-1-HX-ES, LOT # 229175967 WAS ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286026 ↗
• MalfunctionJan 15, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PRIME3D COIL 1-3 WAS SELECTED TO PREPARE TO FORM A HOOP. IT WAS VERY STUCK DURING THE REMOVAL PROCESS, CAUSING THE TAIL END OF THE PUSH ROD TO BE KINKED AND THE DELIVERY SHEATH COULD NOT BE REMOVED. IT WAS REPORTED THAT THE RESISTANCE OCCURRED AT THE HUB. THEN, ANOTHER PRIME3D COIL 1-3 WAS RE-SELECTED TO FORM A HOOP, AND FOUR PRIME2D COILS 1-1 WERE SELECTED AND PLACED INTO THE TUMOR IN SEQUENCE. THE FIRST 1-1 COULD NOT BE PUSHED IN AND THE MICROCATHETER WAS STUCK. THE COIL AND THE MICROCATHETER WERE WITHDRAWN TOGETHER. THE PROBLEM WAS SOLVED AFTER REPLACING THE MICROCATHETER. WHEN DELIVERING THE COIL, THE CATHETER WAS VERY STUCK IN THE DISTAL SECTION AND THE COIL COULD NOT PASS THROUGH. AFTER CHANGING ONE, THE FIRST TWO WERE TIGHT BUT COULD STILL BE USED. THE FOLLOWING COIL WAS ALSO VERY STUCK, AND THE OPERATION WAS BARELY COMPLETED. IT WAS UNKNOWN IF THERE WAS CATHETER DAMAGE. THERE WAS NO COIL DAMAGE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ACCESS VESSEL WAS FEMORAL ARTERY WITH A 9MM DIAMETER. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158907 ↗
• MalfunctionDec 13, 2024Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED REGARDING APB-1.5-2-3D-ES, LOT: 228781450 PART OF COIL WAS IMPLANTED INTO THE PATIENT, WHILE THE OTHER PART OF COIL WAS REMOVED FROM THE PATIENT. ONLY PART OF COIL WAS IMPLANTED INTO THE ANEURYSM. THE COIL THAT FRACTURED IN THE MICROCATHETER WAS REMOVED AND NOT IMPLANTED INTO THE PATIENT. REGARDING THE SECOND COIL IN THE PROCEDURE ABP-1-1-HX-ES, LOT: 228935256 THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS NOT SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. REGARDING THE THRID COIL IN THE PROCEDURE ABP-1-1-HX-ES, LOT: 228935256 DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WASPULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930804 ↗
• MalfunctionDec 13, 2024Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED REGARDING APB-1.5-2-3D-ES, LOT: 228781450 PART OF COIL WAS IMPLANTED INTO THE PATIENT, WHILE THE OTHER PART OF COIL WAS REMOVED FROM THE PATIENT. ONLY PART OF COIL WAS IMPLANTED INTO THE ANEURYSM. THE COIL THAT FRACTURED IN THE MICROCATHETER WAS REMOVED AND NOT IMPLANTED INTO THE PATIENT. REGARDING THE SECOND COIL IN THE PROCEDURE ABP-1-1-HX-ES, LOT: 228935256 THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS NOT¿SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. REGARDING THE THRID COIL IN THE PROCEDURE ABP-1-1-HX-ES, LOT: 228935256 DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WASPULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930573 ↗
• MalfunctionSep 16, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRIED ABOUT 3-5 TIMES TO DETACH THE COIL USING THE INSTANT DETACHER. THEY "FORGOT THE EXACT NUMBER OF TIMES, PROBABLY TRIED SEVERAL TIMES" TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226259 ↗
• MalfunctionSep 3, 2024Stretched; Separation Failure; Stretched; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126906 ↗
• MalfunctionJul 24, 2024Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816741 ↗
• MalfunctionDec 20, 2023Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS NOT IMPLANTED INTO THE PATIENT'S BODY. THE COIL WAS NOT PROTECTED BUT THE PROTECTOR SLEEVE BUT THE PACKAGE HAD NO ISSUE. THE COIL WAS NOT USED ON A PATIENT AND THERE WAS NO PREPARATION DONE TO THE COIL PRIOR TO NOTICING THE DAMAGE. PREMATURE DETACHMENT OCCURRED PRIOR TO USE. THE CATHETER USED WAS AN ECHELON 10. THE DOCTOR USED A TOTAL OF 2 AXIUM COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369633 ↗
• MalfunctionSep 25, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL TIP WAS STRETCHED IN THE MICROCATHETER AND COULDN'T BE PUSHED OUT OR REMOVED. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.  THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9MM. ANCILLARY DEVICES INCLUDE AN ECHELON 105-5091-150  B342206 MICROCATHETER AND A GUIDE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL AFTER REMOVAL AND NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811041 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THE ON-SITE CONTACT, DOCTOR NAME: (B)(6).REPORTED THE EVENT TO MEDTRONIC. THE COIL WAS AUTOMATICALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238515 ↗
• MalfunctionDec 22, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CUSTOMER USED ANOTHER AXIUM COIL AND TRIED MORE 5 TIMES THEN DETACHED COIL. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033286 ↗
• MalfunctionSep 27, 2022Separation Failure; Unintended Movement; Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 3 TEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. TWO ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15489658 ↗
• MalfunctionMar 1, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. ONE ATTEMPT WAS MADE WITH THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE MANUALLY. A SECOND INSTANT DETACHER WAS NOT USED AS THERE WERE NO ISSUES WITH THE FIRST. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY POSTERIOR COMM UNICATING ARTERY. THE MAX DIAMETER WAS 4.3MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637307 ↗