AxiumTM APB-1.5-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00847536021143), received between Mar 14, 2019 and Mar 4, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION OR ARTERIOVENOUS FISTULA. THE LESION GRADE WAS IIB. THE LESION WAS NOT LOCATED IN THE FUNCTIONAL AREA OF THE BRAIN (ELOQUENT AREA). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA TRANSVENOUS EMBOLIZATION (CS D-AVF TVE). THE PHYSICIAN APPROACHED THE CAVERNOUS SINUS (CS) VIA INFERIOR PETROSAL SINUS (IPS) AND WENT INTO SINUS PACKING. SUCCESSFUL PACKING WAS ACHIEVED WITH 15 COILS, AND BACKFLOW WAS ALMOST ELIMINATED; HOWEVER, THE SUBJECT PRODUCT WAS SELECTED AS THE FINAL COIL. THE PLACEMENT WAS COMPLETED AND TRIED TO DETACH, BUT COULD NOT. THE DELIVERY WIRE WAS BROKEN, BUT IT COULD NOT BE DETACHED, SO IT WAS COLLECTED SLOWLY. IT WAS FINISHED WHEN THE PRODUCT WAS RECOVERED SUCCESSFULLY. THERE WAS POOR DISLODGEMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER SEVERAL TIMES. THE PHYSICIAN DID NOT ATTEMPT TO WITHDRAW USING ANOTHER INSTANT DETACHER. THERE WAS 1 ATTEMPT OF MANUAL DISLODGEMENT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506867 ↗
• MalfunctionSep 12, 2025Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS CLARIFIED THE "COIL SEPARATION/BREAK/PREMATURE DETACHMENT" ALLEGATION WAS REFERRING TO THE COIL BODY STRETCH. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS RESISTANCE IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED. THE CATHETER USED IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042531 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE AND WERE NOT DETERMINED. THE COIL WAS REPORTED TO HAVE COME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND NO KINK OR DAMAGE WAS OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794603 ↗
• MalfunctionJul 17, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN TREATING A RIGHT POSTERIOR COMMUNICATING SEGMENT ANEURYSM, WHEN OPENED THE PACKAGE OF A 1.5X2 SPRING COIL, FOUND THAT THE DETACHMENT POINT WAS KINKED. AFTER REPLACING IT WITH A NEW SPRING COIL OF THE SAME MODEL, THE IMPLANTATION WAS SUCCESSFUL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY SEGMENT WITH A MAX DIAMETER OF 4.2MM AND A 2.3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SEALED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763852 ↗
• MalfunctionJun 18, 2024Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL HAD MIGRATED AFTER PLACEMENT AND BECAME ENTANGLED WITH ANOTHER COIL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY ANCHOR WITH A MAX DIAMETER OF 4.5 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE 5TH COIL HAS BEEN IMPLANTED, BUT WHEN ATTEMPTING TO REWIND IT, THE 4TH COIL (THE COIL THAT CAUSED THE DEFECT THIS TIME) BECAME STUCK IN THE 5TH COIL. THE MICROCATHETER WAS REMOVED FROM THE SYSTEM, SO THE COIL COULD NOT BE MOVED DISTALLY. IT WAS REPORTED THERE WAS MIGRATION AFTER PLACEMENT. THE CAUSE OF THE MIGRATION WAS IT BECAME ENTANGLED IN THE 5TH COIL. PERHAPS THE BALL PART OF THE CONNECTION BETWEEN THE COIL AND DELIVERY WIRE OF THE 4TH COIL (THE COIL THAT CAUSED THE DEFECT THIS TIME) HAD PROTRUDED. THE COIL WAS NOT PLACED IN THE INTENDED POSITION AS IT WAS REMOVED FROM THE PATIENT. 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 19558012 ↗
• MalfunctionMar 29, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED A2/PERICALLOSAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COMPLEX STENT COIL, DISTAL ANATOMY THAT DID WAS NOT AMENABLE TO DUAL MICROCATHETER PLACEMENT. ATLAS STENT WAS DEPLOYED WITH NO COMPLICATION. DUE TO 1 MICROCATHETER BEING USED, THEY HAD TO RE-ACCESS THE ANEURYSM THROUGH THE STENT (NOT UNCOMMON). THEY ENCOUNTERED SOME RESISTANCE ON THE PROXIMAL TINES OF THE STENT WITH THE MICROCATHETER (017 MC, 014 WIRE). THE STENT DID SLIGHTLY MIGRATE PROXIMAL TO DISTAL BUT NOTHING THAT PREVENTED FROM CONTINUING. THEY CONTINUED TO HAVE DIFFICULTY GETTING THROUGH THE STENT TO THE ANEURYSM WITH MULTIPLE ATTEMPTS. ONCE THEY DID GET ACCESS, THE MICROCATHETER TIP WAS IN THE SMALLER OF THE 2 LOBES OF THE ANEURYSM. TRIED TO DEVIATE BUT THE MICROCATHETER HAD A WEIRD SHAPE. THE DECISION TO DELIVER THE FIRST COIL WAS MADE. THE FIRST COIL 3.5 X 6 FRAME WAS ABLE TO FORM PROPERLY AND FILL IN SPACES THAT THEY WANTED. THE DETACHER WAS USED PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004309 ↗
• MalfunctionJan 23, 2024Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH AND WAS FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4.7 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS LOCATED IN THE POSTERIOR COMMUNICATING ARTERY AND THE SIZE OF THE ANEURYSM WAS 4.25MM X 4.7MM. AFTER THE ECHELON-10 MICROCATHETER WAS IN PLACE, QC-4-12-3D WAS USED FOR FORMING HOOP. FILLING IN THE ORDER, APB-3-8-3D-ES, QC-2-4-3D, APB-1-5-4D-ES, APB-1.5-4-HX-ES, APB-1.5-3-3D- ES, FINALLY FILLING IN THE APB-1.5--2D-E COIL. ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS DENSELY EMBOLIZED, AND THE APB-1.5-2-3D COIL WAS IMPLANTED FOR FINAL DETACHMENT. HOWEVER, THE COIL COULD NOT BE DETACHED AFTER SEVERAL ATTEMPTS. LATER, AN ATTEMPT WAS MADE TO MECHANICALLY DETACH THE SPRING COIL, WHICH WAS STRETCHED AND LEFT IN THE BLOOD VESSEL. A THROMBECTOMY STENT WAS USED TO REMOVE THE STRETCHED SPRING COIL FROM THE BODY. THE ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS DENSELY FILLED AND THERE WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565613 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS RESISTANCE LOCATED IN THE PROXIMAL SECTION OF THE CATHETER. THE COIL CAME OUT SMOOTHLY FROM THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476980 ↗
• MalfunctionJan 3, 2024Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS IMPLNATED IN THE PATIENT. IT WAS NOT IMPLANTED AT THE INTENDED LOCATION. NO MEDICAL OR SURGICAL INTERVENTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440488 ↗
• MalfunctionJun 8, 2023Stretched; Separation Failure; Stretched; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THERE ARE NO IMAGES OF THE DEVICE(S) AVAILABLE. THE CAUSE OF THE COIL NON DETACHMENT MUST BE TO RTUOSITY. THE INSTANT DETACHER LOT NUMBER WAS B264516. 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 17087230 ↗
• MalfunctionMay 9, 2023Stretched; Migration; Stretched; Migration

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE FOUND STRETCHED AND MIGRATED AFTER DEPLOYMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL WAS STRETCHED AS IT ENTERED THE ANEURYSM FOR FILLING. IT WAS REPORTED MIGRATION AFTER DEPLOYMENT OCCURRED. THE CAUSE OF THE MIGRATION WAS THE COIL WAS STRETCHED. THE COIL WAS NOT IMPLANTED I THE INTENDED LOCATION. THE COIL WAS IMPLANTED IN THE RIGHT OPHTHALMIC ARTERY. 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. ANCILLARY DEVICES INCLUDE A MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895033 ↗
• MalfunctionAug 23, 2022Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL BECAME STRETCHED. IT WAS NOTED THAT THE COIL HAD BEEN REPOSITIONED OVER 5 TIMES. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276801 ↗
• MalfunctionAug 12, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL WAS THE LAST TO BE USED IN THE LEFT INTERNAL CAROTID ARTERY COILING PROCEDURE. THE COIL COULD NOT BE DETACHED DESPITE TRYING MANY TIME. THE SURGEON ATTEMPTED MORE THAN 5 TIMES TO DETACH THE COIL WITH THE INSTANT DETACHER WITHOUT SUCCESS. ANOTHER INSTANT DETACHER WAS ALSO TRIED MORE THAN 5 TIMES WITHOUT SUCCESS. IT WAS NOTED THERE WAS NO PROBLEM WITH THE INSTANT DETACHERS. SINCE THE COIL COULD NOT BE DETACHED, THE SURGEON REMOVED IT. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218942 ↗
• MalfunctionJun 7, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS EXTENDED. THE PRODUCT SOMEHOW INSERTED AFTER INSERTING AND RETRACTING SEVERAL TIMES. DETACHMENT WAS ATTEMPTED WITH THE ID-1, BUT DETACHMENT WAS NOT POSSIBLE. THIS WAS REPEATED ABOUT 3 TIMES BUT DETACHMENT WAS NOT POSSIBLE SO A DIFFERENT ID-1 WAS USED BUT IT COULD NOT DETACH AS WELL. ALTHOUGH MANUAL DETACHMENT WAS PERFORMED USING THE BREAK INDICATOR, THE MIDDLE RELEASE ELEMENT WAS DISCONNECTED AND COULD NOT BE DETACHED. IN ADDITION, THE DISTAL DELIVERY PUSHER WAS FOLDED AND DETACHMENT WAS ATTEMPTED BUT IT WAS NOT POSSIBLE, HENCE IT WAS REMOVED FROM THE PATIENT'S BODY. HOWEVER, IT WAS BROKEN, SO THE ENTIRE MICROCATHETER WAS REMOVED OUT OF THE PATIENT'S BODY USING A SNARE. THE EMBOLIZATION WAS SUFFICIENT AND THE PROCEDURE WAS COMPLETED AS IS. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS NOT REPOSITIONED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ACOM WITH A MAX DIAMETER OF 5MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622220 ↗
• MalfunctionMay 27, 2022Migration; Migration

  (B)(6) 2022 MPXR 953014 (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS PULLED FROM THE ANEURYSM SAC DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR C5 ARTERY SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. 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). THE COIL WAS THE FINAL COIL BEING USED IN THE PROCEDURE. AFTER DETACHMENT, THE PUSHWIRE WAS REMOVED AND IT WAS INTENDED TO END THE SURGERY. HOWEVER, WHEN THE MICROCATHETER WAS REMOVED, THE TAIL OF THE COIL WAS PULLED OUT OF THE ANEURYSM SAC. A STENT WAS THEN USED TO PRESS THE COIL BACK INTO PLACE IN THE ANEURYSM. THERE WAS NO HARM OR INJURY TO THAT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522585 ↗
• MalfunctionJan 7, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE FIRST INSTANT DETACHER, AND 2 ATTEMPTS WERE MADE WITH A SECOND INSTANT DETACHER. TWO ATTEMPTS WERE MADE MANUALLY, AND THE COIL STILL COULD NOT BE DETACHED. THERE WERE NO ISSUES WITH THE INSTANT DETACHERS. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A FUBUKI 8F GUIDE CATHETER AND A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192384 ↗
• MalfunctionDec 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT WHEN INSERTING THE AXIUM COIL INTO THE ANEURYSM, CONSIDERABLE RESISTANCE WAS FELT, AND THE COIL DETACHED WITHIN THE PHENOM 17 CATHETER, WHEN THE COIL WAS PULLED. FLUSHING WAS PERFORMED UNINTERRUPTEDLY DURING THE PROCEDURE. NO DAMAGES WERE NOTICE ON THE CATHETER OR THE COIL. RESISTANCE WAS FELT WHEN THE COIL WAS DELIVERED. THE COIL WAS NOT REPOSITIONED. THE COIL WAS NOT ATTEMPTED TO BE DETACHED. THE PUSHWIRE WAS NOT ROTATED. THIS EVENT OCCURRED DURING THE TREATMENT OF ANTERIOR COMMUNICATING ARTERY (ACOM), UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 4.7MM AND THE NECK WAS 3.1MM. THE BLOOD FLOW WAS NORMAL. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512831 ↗
• MalfunctionAug 14, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME BARE FAILED TO BE DETACHED WITH 2 INSTANT DETACHERS. WHEN THE DETACHER WAS USED UNDER THE STATE OF REVERSE T FOR THE SECOND MARK OF MICROCATHETER AND DETACHER MARK OF THE COIL, IT FAILED. THE FIRST INSTANT DETACHER WAS USED 4 TIMES TO ATTEMPT TO DETACH THE COIL. THE SECOND DETACHER WAS USED 2 TIMES. MANUAL DETACHMENT WAS NOT ATTEMPTED. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT IC-PC UNRUPTURED ANEURYSM. THE MAX DIAMETER WAS 4.5MM AND THE NECK WAS 2MM. THE BLOOD FLOW WAS NORMAL, AND THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY REPORTED. NO IMAGES ARE AVAILABLE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8893609 ↗
• MalfunctionMay 1, 2019Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM IMPLANT COULD NOT BE DETACHED DURING AN EMBOLIZATION PROCEDURE. PRIOR TO THE EVENT, TWO TARGET COILS HAD BEN IMPLANTED IN THE ANEURYSM WITH ¿SIMPLE TECHNIQUE¿. THEN THE REPORTED AXIUM PRIME COIL WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AND DELIVERED THROUGH THE SL10 MICROCATHETER THAT WAS ALREADY IN PLACE IN THE ANEURYSM. THE COIL WAS PLACED INSIDE THE ANEURYSM AND AN INSTANT DETACHER WAS USED TO DETACH THE COIL AND THAT WAS WHEN THE REPORTED EVENT OCCURRED. THE PHYSICIAN HAD THOUGHT THAT THE COIL DETACHED SMOOTHLY, BUT FOUND THE COIL TO MOVE WITH THE PUSHWIRE AS IT WAS BEING REMOVED. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE COIL USING THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) AND PULLED BACK THE RELEASE WIRE FOR 3CM AND THEN PULLED BACK THE PUSHWIRE, BUT THE COIL STILL CAME ALONG. THE PHYSICIAN PUSHED THE PUSHWIRE TO SLIGHTLY EXCEED THE SECOND MARKER OF THE REVERSE T, BUT THE COIL STILL CAME ALONG WITH THE PUSHWIRE AS IT WAS PULLED OUT AND DETACHED INSIDE THE MICROCATHETER. AT THIS POINT, THE PHYSICIAN TRIED TO PUSH THE COIL INTO THE ANEURYS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8570066 ↗
• MalfunctionMar 14, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE AXIUM IMPLANT COIL WAS DETACHED WITH THE INSTANT DETACHER, THE PHYSICIAN WITHDREW THE PUSHWIRE INTO THE MICROCATHETER AND SAW THAT THE IMPLANT COIL WAS ALSO MOVING BACK INTO THE MICROCATHETER. THEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL ALONG WITH THE MICROCATHETER, BUT THE COIL WAS DRAWN BACK INTO THE ANEURYSM SOMEHOW AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE INSTANT DETACHER (ID) WAS BRAND NEW. 2 DETACHMENT ATTEMPTS WERE MADE WITH THE ID. THE PROXIMAL END OF THE PUSHWIRE WAS NOT DAMAGED. THE DEVICES WERE ALL DISCARDED AT THE SITE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN ANEURYSM (DISTORTED) MEASURING 4MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420723 ↗