AxiumTM APB-3-6-3D-ES (UDI 00847536021235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00847536021235), received between Jan 25, 2019 and Aug 11, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (18 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Deformation; Packaging Problem

  Medtronic received a report that an Axium coils were kinked. It was reported that during the preparation stage, when the product was being removed from the sheath, the delivery wire was kinked. Damage was observed on the pusher at the proximal section. Considering that it is a wire¿type coils, it was not used and was replaced with an equivalent product. All devices were prepared as indicated in the IFU. No patient complications were associated with this event. Additional information was received that the treated aneurysm was approximately 3 mm located at the anterior communicating artery. There was nothing in particular regarding damage or evidence of tampering to device packaging. The proximal end of the¿push wire¿was secured in the guidewire clip (black rubber stopper) when the¿package was¿opened.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201962 ↗
• MalfunctionJan 28, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME ES 3D COIL WAS USED FOR THE FIRST FRAMING COIL, AND ALTHOUGH THE COIL WAS INSERTED INTO THE ANEURYSM UP TO THE DETACHMENT POINT, DETACHMENT COULD NOT BE ACHIEVED. INITIALLY, DETACHMENT WAS ATTEMPTED 3 TIMES USING THE INSTANT DETACHER, BUT IT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE DELIVERY WIRE WAS MANUALLY BENT AND PULLED ONE TIME, BUT THE COIL STILL COULD NOT BE DETACHED AND WAS RETRIEVED FROM THE BODY. THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, CEREBRAL ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ATTEMPTS TO WITHDRAW (DETACH) USING ANOTHER INSTANT DETACHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201723 ↗
• MalfunctionJan 28, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHILE INSERTING THE AXIUM PRIME BARE 3D COIL INTO THE ECHELON 45° CATHETER, AN UNUSUAL RESISTANCE WAS NOTED. SIMILAR RESISTANCE WAS ALSO FELT DURING THE REMOVAL. COIL RESISTANCE/STUCK WITHIN SHEATH WAS ALSO REPORTED. UPON INSPECTION AFTER REMOVAL, THE FORMATION OF A KNOT-LIKE STRUCTURE WAS OBSERVED. THE COIL WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANTERIOR COMMUNICATING ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED: ASAHI FUBUKI GUIDECATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201390 ↗
• MalfunctionNov 26, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT EXPERIENCED NO PROBLEMS AND NO SYMPTOMS RELATED TO THE NON-DETACHMENT AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE DEVICE WITH A MEDTRONIC PRODUCT. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. IT WAS CLARIFIED THAT POOR DISLODGEMENT REFERS TO THE NON-DETACHMENT OF THE AXIUM COIL. IT WAS NOTED THAT THERE WAS A SIMILAR EVENT IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657578 ↗
• MalfunctionNov 5, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT AN AXIUM COIL PUSHER WIRE WAS FOUND TO BE BENT WHEN THE DEVICE WAS REMOVED FROM THE HOUSING. THERE HAD BEEN NO PREPARATION OR FLUSHING DUE TO THE ISSUE BEING OBSERVED PRIOR TO USE. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482450 ↗
• MalfunctionJun 10, 2025Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT FOR AN ANEURYSM WITH THE AXIUM PRIME BARE 3D 3MM X 6CM EXTRA SOFT, THE COIL WOULD NOT DETACH AND THE BACK OF THE COIL WAS KINKED AT THE DETACHER INTERFACE IN THE PUSHWIRE PROXIMAL SEGMENT. AN ATTEMPT TO RETRIEVE THE COIL WAS UNSUCCESSFUL, AND THE COIL DETACHED INTO THE PARENT VESSEL AND OUT OF THE ANEURYSM SAC. A PUFF OF CONTRAST WAS USED TO PUSH THE COIL BACK INTO THE ANEURYSM SAC. THE PUSHER WAS REPORTED TO BE KINKED OR BROKEN, WITH DEVICE DAMAGE NOTED AT THE PUSHWIRE PROXIMAL SEGMENT. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE DEIVCES WERE PREPARED ACCORIDNG TO THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180949 ↗
• MalfunctionApr 2, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED NO PUSHWIRE¿DAMAGE AFTER REMOVAL FROM THE PATIENT. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. THE FIRST COIL (LOT: 228781478) COULD NOT BE REMOVED, SO A FORCED SEPARATION WAS PERFORMED; THE SECOND COIL (LOT: 228893130) WAS ALSO TESTED, BUT IT COULD NOT BE REMOVED, SO FORCED SEPARATION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759331 ↗
• MalfunctionJan 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE AXIUM PRIME BARE 3D 3MM X 6CM EXTRA SOFT COIL ENCOUNTERED RESISTANCE AT THE CATHETER HUB WHEN ATTEMPTING TO INSERT THE COIL INTO THE CATHETER. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. AS A RESULT OF THE RESISTANCE, THE COIL WAS NOT USED, AND ANOTHER AXIUM COIL WAS UTILIZED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT. THE CATHETER WAS NOT MANUFACTURED BY MEDTRONIC. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK OR OTHER DAMAGE OBSERVED TO THE COIL OR THE CATHETER. THE CAUSE OF THE RESISTANCE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287439 ↗
• MalfunctionJan 9, 2025Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IT WAS UNKNOWN IF BREAK/SEPARATION/PREMATURE DETACHMENT. THE CAUSE OF THE EVENT 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 21111908 ↗
• MalfunctionSep 19, 2024Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH AND WAS STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) ASSOCIATED WITH A RUPTURED LEFT ANTERIOR CEREBRAL ARTERY (ACA) SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERY FROM THE MICROCATHETER AND TWO ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) BUT DETACHMENT ATTEMPTS FAILED. A SECOND ID WAS NOT TRIED AND MANUAL DETACHMENT WITH THE HYPOTUBE WAS ALSO NOT ATTEMPTED. DURING THE THIRD INSERTION ATTEMPT THE COIL UNRAVELED TO THE SYSTEM WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ASSOCIATED HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: XT-17 CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261684 ↗
• MalfunctionMay 13, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT C5 WITH A MAX DIAMETER OF 3.9 MM AND A 1.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE ANEURYSM COIL EMBOLIZATION, AFTER PUSHING 3-6 SPRING COIL INTO PLACE, THE COIL COULD NOT BE DETACHED. AFTER REPLACING WITH THE SAME MODEL OF SPRING COIL, IT ENDED SUCCESSFULLY. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER TWO TIMES. THE PHYSICIAN DID NOT TRY TO DETACH THE COIL WITH ANOTHER INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299060 ↗
• MalfunctionJan 30, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH AND ENCOUNTERED RESISTANCE IN THE CATHETER UPON RETRIEVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM SPRING COIL ES COULD NOT BE DETACHED NORMALLY DURING ANEURYSM EMBOLIZATION AND WAS BLOCKED IN THE MIC ROCATHETER. AFTER MULTIPLE OPERATIONS TO NO AVAIL, IT WAS RETRIEVED INTO THE MICROCATHETER AND WAS BLOCKED IN THE MICROCATHETER WHEN IT WAS READY TO BE WITHDRAWN. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH A SECOND INSTANT DETACHER THREE TIMES. THERE WERE THREE MANUAL ATTEMPTS MADE AT DETACHING THE COIL VIA HYPOTUBE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608782 ↗
• MalfunctionDec 15, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH AND WAS FOUND STUCK IN THE ECHELON MICROCATHETER. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION FOR TREATMENT OF AN AMORPHOUS, RUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT FOR A MIDDLE CEREBRAL ANEURYSM, COIL EMBOLIZATION WAS PERFORMED. AFTER THE MICROCATHETER WAS IN PLACE, THE APB-3-6-3D-ES COIL WAS DELIVERED AND THE DETACHMENT AREA WAS MANUALLY BROKEN, BUT THE COIL WAS NOT DETACHED. THEN IT WAS WITHDRAWN, BUT IT WAS FOUND THAT THE COIL WAS STUCK AT THE PROXIMAL END OF THE MICROCATHETER. SO THEY WERE WITHDRAWN AS A WHOLE AND RETURNED FOR IDENTIFICATION. IT WAS ALSO REPORTED NONDETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 0 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336127 ↗
• MalfunctionOct 20, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE HCP NOTED THERE WAS NOTHING IN PARTICULAR REGARDING ISSUES PRIOR TO COIL NON-DETACHMENT AS THEY WERE ABLE TO CUT NORMALLY UNTIL THEN. THERE WAS NO PARTICULAR PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976016 ↗
• MalfunctionOct 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN OBVIOUS DEFECT WITH THE COIL COULD NOT BE SEEN. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641204 ↗
• MalfunctionSep 30, 2022Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY C5 SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4.5MM AND THE NECK DIAMETER WAS 2.6MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS DELIVERED THROUGH THE MICROCATHETER AND PUSHED OUT TO FORM THE HOOP BUT IT WAS FOUND THAT THE AXIUM COIL DEVICE WAS BROKEN. IT WAS NOTED THAT THE DAMAGE WAS TO THE COIL AND THE PUSHWIRE WAS KINKED. THE MICROCATHETER WAS WITHDRAWN FROM THE PATIENT'S BODY AND THE COIL WAS REPLACED WITH ANOTHER OF THE SAME MODEL TO CONTINUE. OTHER COILS WERE SUCCESSFULLY DELIVERED AND IMPLANTED AFTERWARD TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509580 ↗
• MalfunctionAug 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN SACCULAR INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE SHEATH WAS FLUSHED BEFORE TAKING OUT THE COIL. WHEN THE PHYSICIAN TRIED TO PUSH THE COIL OUT, THE COIL WAS STUCK AND DAMAGED. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WERE NO PATIENT COMPLICATIONS OR INJURIES ASSOCIATED WITH THE EVENT. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15204100 ↗
• MalfunctionDec 21, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT DURING INSERTION OF THE COIL IN THE MICROCATHETER, THE COIL WAS PREMATURELY DETACHED INTO THE MICROCATHETER. THE COIL WAS REMOVED TO AVOID THE DETACHMENT FROM THE MICROCATHETER. IT WAS INDICATED THE COIL WAS DAMAGED. THE COIL WAS REMOVED WHILE IT WAS STILL IN THE MICROCATHETER. NO SURGICAL OR MEDICINAL INTERVENTIONS WERE REQUIRED. IT WAS UNKNOWN IF THERE WAS DAMAGE TO THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS NOT REPOSITIONED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL AND THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. ANCILLARY DEVICES INCLUDE: SL-10 STRYKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056543 ↗
• MalfunctionSep 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SECOND COIL DELIVERED GOT STUCK 1CM INTO THE HUB OF THE MICROCATHETER, AND DIDN'T MOVE WHEN PUSHED OR PULLED. THE DEVICE WAS THEN ABLE TO BE PULLED OUT OF THE MICROCATHETER ONCE THE COIL UNRAVELED AND WAS RETRIEVED. THE DEVICE WAS REPLACED WHICH WAS USED WITHOUT ISSUE. THE COIL WAS ABLE TO BE PUSHED SMOOTHLY FROM THE SHEATH, AND NO DAMAGE WAS SEEN ON THE COIL OR MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT OF AN AMORPHOUS, RUPTURED, A-COM ANEURYSM WITH A MAX DIAMETER OF 4MM AND A NECK WIDTH OF 2.5MM. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW SPEED AND VESSEL TORTUOSITY WERE NORMAL. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A FUBUKI 6F GUIDE CATHETER, PHENOM 17 MICROCATHETER, CHIKAI GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493503 ↗
• MalfunctionAug 30, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO ISSUE IN PARTICULAR NOTICED PRIOR TO THE NON-DETACHMENT. IT WAS UNKNOWN WHETHER THERE WAS PUSHWIRE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388447 ↗
• MalfunctionAug 6, 2021Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENTS WERE MADE WITH THE FIRST COIL. THE SECOND COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WAS NO KINK/DAMAGE OBSERVED TO EITHER PUSHWIRE. THE PATIENT WAS TRANSFERRED TO NEUROSURGERY FOR CLIPPING AFTER THE PROCEDURE. THE PATIENT CURRENTLY HAS ISCHEMIA LOCALIZED AT THE BRAIN AREA THAT THE THROMBOSED BRUNCH OF THE MCA WAS SUPPLYING.

  Patient problems: Ischemia; Thromboembolism

  MAUDE report 12288245 ↗
• MalfunctionJul 7, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED AFTER NON-DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC). THE MAX DIAMETER WAS 4.9MM, AND THE NECK DIAMETER WAS 2.9MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST FRAME COIL WAS REWOUND 5 TIMES AND DETACHMENT WAS PERFORMED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS COLLECTED, AND IT WAS CONFIRMED THAT THE COIL WAS STILL ATTACHED AND DID NOT DETACH. THE PUSHWIRE WAS ATTEMPTED TO BE DETACHED AGAIN, BUT IT WAS CONFIRMED TO HAVE NOT DETACHED AGAIN. AFTER THE NON-DETACHMENT, THE BREAK INDICATOR MANUAL DETACHMENT MECHANISM WAS MANUALLY FOLDED AND THE RELEASE WIRE INSIDE WAS PULLED BY ABOUT 3CM AND DETACHED. WHEN THE PUSHWIRE WAS COLLECTED, THE COIL WAS STILL NOT DETACHED. THE WORK OF DETACHING THE COIL OVER THE REVERSE T BY 1MM WAS PERFORMED ABOUT 4 TIMES, BUT THE COIL STILL COULD NOT BE DETACHED. THE COIL WAS DECIDED TO BE COLLECTED. ABOUT 4CM WAS COLLECTED IN THE CATHETER, BUT THE REMAINING 2CM REMAINED IN THE ANEURYSM. D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129126 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED INDICATED THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION: THE LOOK DEVIATED FROM THE MOTHER BLOOD VESSEL. THERE WAS NO SURGICAL INTERVENTION, BUT THE BLOOD FLOW WAS POOR AND MEDICATION WAS GIVEN TO TREAT. THE VESSEL TORTUOSITY WAS NOT STRONG, AND IT WAS DIFFICULT TO INVESTIGATE THE CAUSE OF THE ISSUE EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778190 ↗
• MalfunctionApr 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE DEVICE WAS INSERTED INTO THE MICROCATHETER AND DEPLOYED IN THE ANEURYSM, THE TIP OF THE DELIVERY PUSHER'S HAND SIDE WAS EXTENDED 7MM OR MORE WHILE NOTHING WAS DONE. IT WAS SLOWLY REMOVED FROM THE ANEURYSM IN A HURRY, BUT IT WAS PULLED HALFWAY BECAUSE IT HAD ALREADY BEEN DETACHED, BUT THE COIL CAME OFF INSIDE THE GUIDE CATHETER. THE ENTIRE GUIDE CATHETER WAS REMOVED FROM THE BODY. AFTERWARDS, THE DEVICE WAS INDUCED TO THE ANEURYSM AGAIN AND ANOTHER COIL WAS USED. THE TREATMENT WAS COMPLETED WITHOUT ANY PROBLEMS, AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE NEEDED. THERE HAD BEEN NO RESISTANCE DURING DELIVERY, AND THE COIL HAD NOT BEEN RELOCATED. THERE HAD BEEN NO ATTEMPTS MADE TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODE, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661466 ↗
• MalfunctionJan 13, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATED THAT MORE THAN 5 INSTANT AND MANUAL DETACHMENT ATTEMPTS WERE MADE. THERE WERE NO ISSUES PRIOR TO THE NON-DETACHMENT, AND NO DAMAGE WAS SEEN ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167149 ↗