Axium Prime Detachable Coil System APB-2-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000313906), received between Dec 20, 2021 and May 7, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS TWISTED AND COULD NOT BE DEPLOYED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113304 ↗
• MalfunctionMar 18, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE PROXIMAL END OF THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 1.2 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10 MM DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER PUNCTURE, AN ECHELON10 MICROCATHETER WAS ADVANCED TO THE LESION SITE. THE FIRST COIL SELECTED WAS AXIUM. WHEN ADVANCING THE COIL TO THE MIDDLE SEGMENT OF THE MICROCATHETER, THERE WAS SIGNIFICANT RESISTANCE, AND MULTIPLE ATTEMPTS TO DELIVER WERE UNSUCCESSFUL. THE COIL BECAME STUCK INSIDE THE MICROCATHETER AND COULD NOT BE RETRIEVED. THE OPERATOR HAD TO REMOVE BOTH THE MICROCATHETER AND THE COIL TOGETHER FROM THE BODY. IT WAS UNCLEAR WHETHER THE ISSUE WAS DUE TO THE MICROCATHETER OR THE COIL. THE OPERATOR THEN SWITCHED TO A MICROCATHETER AND COIL FROM ANOTHER MANUFACTURER. THE COIL WAS SUCCESSFULLY ADVANCED AND DETACHED THROUGH THE MICROCATHETER, AND SUBSEQUENT COILS WERE FILLED SMOOTHLY. ANGIOGRAPHY SHOWED DENSE FILLING OF THE ANEURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626333 ↗
• MalfunctionFeb 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.53 MM AND A 3.24 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.   IT WAS REPORTED THAT THE ECHELON 10 MICROCATHETER WAS DELIVERED INTO THE ANEURYSM SAC VIA A 6F INTERMEDIATE CATHETER. THE COIL WAS ADVANCED THROUGH THE ECHELON 10 MICROCATHETER. DURING DELIVERY, THE OPERATOR NOTED SIGNIFICANT RESISTANCE, AND UPON REACHING THE DISTAL END OF THE MICROCATHETER, THE COIL COULD NOT BE NORMALLY PUSHED OUT OF THE MICROCATHETER. THEREFORE, A SECOND COIL WAS USED INSTEAD FOR EMBOLIZATION; HOWEVER, THE SAME ISSUE REOCCURRED. 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 RECEIVED REPORTED THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE AS INDICATED IN THE IFU. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248291 ↗
• MalfunctionJan 9, 2026Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT C6 VESSEL SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 3.4MM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS ADVANCED BUT IT WAS NOTED THAT THE COIL DETACHED BEFORE REACHING THE ANEURYSM. THE PUSHER WAS WITHDRAWN AND A CAPTURE DEVICE WAS USED TO RETRIEVE THE COIL FROM THE PATIENT'S BODY. IT WAS NOTED THAT THE COIL PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN HAD NOT ROTATED THE DELIVERY WIRE AND HAD NOT ATTEMPTED TO DETACH THE COIL. THERE WAS NO OTHER PATIENT SYMPTOM, COMPLICATION, OR INJURY ASSOCIATED WITH THIS EVENT. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24022446 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY IN AN ECHELON 10 MICROCATHETER AND DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A RIGHT ANTERIOR COMMUNICATING ARTERY (ACOM) RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. PATIENT'S BLOOD FLOW WAS NORMAL; VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED CONTINUOUSLY AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ECHELON MICROCATHETER WAS DELIVERED IN PLACE WITH THE GUIDEWIRE AND THE AXIUM COIL WAS SELECTED. HOWEVER, THE COIL EXPERIENCED SEVERE RESISTANCE AND COULD NOT BE ADVANCED THROUGH THE MIDDLE SEGMENT OF THE MICROCATHETER. WHEN THE COIL WAS WITHDRAWN, IT WAS OBSERVED THAT THE COIL HAD DETACHED PREMATURELY. THE SURGEON QUICKLY REMOVED THE MICROCATHETER AND THE GUIDEWIRE WAS USED TO PUSH THE COIL OUT OF THE MICROCATHETER IN VITRO, CONFIRMING THE COIL HAD DETACHED WITHIN THE MICROCATHETER. THERE WAS NO DAMAGE TO THE AXIUM PUSHWIRE. THE PHYSICIAN DID NOT ROTATE THE PUSHWIRE AND HAD NOT ATTEMPTED TO REPOSITION OR DETACH THE COIL. THE CATHETER AND COIL WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019553 ↗
• MalfunctionNov 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. THE SURGEON WAS UNSURE WHETHER THE PROBLEM WAS WITH THE COIL OR THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513018 ↗
• MalfunctionAug 15, 2025Migration; Physical Resistance/Sticking; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON 10 45° PRE-SHAPED TIP CATHETER WAS KINKED, BECAME ENTANGLED WITH AN AXIUM PRIME BARE COIL, AND UNINTENTIONALLY PULLED IT FROM THE ANEURYSM. THE PATIENT WAS UNDERGOING INTERVENTIONAL EMBOLIZATION FOR TREATMENT OF AN INTERNAL CAROTID ARTERY ANEURYSM. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE AXIUM PRIME BARE DETACHABLE SPRING COIL (APB-2-8-HX-ES) WAS DELIVERED INTO POSITION WITHIN THE ANEURYSM. WHEN READY FOR DETACHMENT, THE MICROCATHETER PULLED THE SPRING COIL OUT OF THE ANEURYSM NECK, CAUSING IT TO BE COMPLETELY WITHDRAWN. THE MICROCATHETER WAS FOUND TO BE BROKEN/KINKED IN THE DISTAL REGION. A MEDTRONIC ECHELON 0° MICROCATHETER AND AXIUM PRIME BARE DETACHABLE SPRING COIL (APB-2-6-HX-ES) WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815454 ↗
• MalfunctionAug 1, 2025Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED. THE HX 2X6 COIL USED WAS AN OPTIMA HELICAL 2X6 COIL, AND NO ANTIPLATELET REGIMEN WAS GIVEN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689116 ↗
• MalfunctionApr 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA (CCF) USING AN AXIUM PRIME COIL, THE COIL GOT STUCK BEFORE ENTERING THE COILING CATHETER. A SIGNIFICANT RESISTANCE WAS FELT WHEN ATTEMPTING TO PUSH THE COIL INTO THE CATHETER, AND IT WAS DISCOVERED THAT THE COIL WAS STUCK IN THE SHEATH. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NOT A CONTINUOUS FLUSH. THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756387 ↗
• MalfunctionMar 31, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A CEREBRAL C4 ANEURYSM, THE AXIUM PRIME BARE HX COIL DETACHED BY ITSELF DURING DELIVERY IN THE ECHELON 10 MICROCATHETER LUMEN AND COULD NOT BE DELIVERED TO THE LESION SITE. AFTER REPLACING THE COIL WITH A NEW ONE, IT WAS SUCCESSFULLY DEPLOYED AND DETACHED. THE ANEURYSM WAS UNRUPTURED WITH A SACCULAR MORPHOLOGY, A MAXIMUM DIAMETER OF 3MM, AND A NECK DIAMETER OF 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THE TIP OF THE CATHETER WAS MOVED DURING DEPLOYMENT, BUT THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED AND THE ANEURYSM DID NOT RUPTURE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. IT WAS NOTED THERE WAS DIFFICULT PLACEMENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730962 ↗
• MalfunctionMar 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY COMMUNICATING SEGMENT, RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY OF THE APB-2-8-HX-ES SPRING COIL INTO THE PROXIMAL END OF THE MICROCATHETER, PREVENTING SMOOTH DELIVERY. THE COIL WAS REPLACED WITH A QC-2-6-HELIX COIL, WHICH WAS DELIVERED SUCCESSFULLY. SUBSEQUENTLY, RESISTANCE WAS ALSO ENCOUNTERED DURING THE DELIVERY OF THE QC-2-8-HELIX AND QC-2-4-HELIX COILS INTO THE PROXIMAL END OF THE MICROCATHETER, PREVENTING SMOOTH DELIVERY. THESE COILS WERE REPLACED WITH OTHER MODELS, WHICH WERE SUCCESSFULLY DELIVERED. THE SURGEON BELIEVED THAT THE APB-2-8-HX-ES, QC-2-8-HELIX, AND QC-2-4-HELIX COILS HAD QUALITY ISSUES AND REQUESTED THEIR RETURN FOR IDENTIFICATION. THE CATHETER WAS NOT DAMAGED, AND THE COILS WERE NOT IMPLANTED. THE PATIENT¿S BLOOD FLOW WAS REPORTED AS NORMAL, AND THE VESSEL TORTUOSITY WAS MINIMAL. THE ANEURYSM HAD A MAX DIAMETER OF 4 MM AND A NECK DIAMETER OF 2.5 MM. THE PROCEDURE WAS COMPLETED USING ALTERNATIVE COILS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529058 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS FOUND PREMATURELY DETACHED PRIOR TO USE. IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT VERTEBRAL ARTERY (VA) RUPTURED DISSECTING ANEURYSM, THE AXIUM COIL WAS FOUND TO BE ALREADY DETACHED UPON OPENING THE PACKAGE, THOUGH THE REPORTED INFORMATION INDICATED THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE WAS NOT BENT OR OTHERWISE DAMAGED. THERE WAS NO FRICTION/RESISTANCE OR OTHER DIFFICULTY. THE PHYSICIAN HAD NOT REPOSITIONED OR ATTEMPTED TO DETACH THE COIL AND DID NOT ROTATE THE DELIVERY PUSHER. THE ISSUE IDENTIFIED BEFORE IMPLANTATION AND WAS NOT USED IN THE PROCEDURE. THEREFORE, IT IS CONSIDERED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079987 ↗
• MalfunctionNov 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN A MICROCATHETER AND A MICROCATHETER WAS DAMAGED. 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 MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY.  IT WAS REPORTED THAT DURING INTRACRANIAL ANEURYSM EMBOLIZATION, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS DAMAGED AFTER SHAPING. AFTER ANOTHER MICROCATHETER WAS USED IN PLACE, THE DETACHABLE COIL WAS SELECTED FOR FORMING A HOOP. FINALLY, THE APB-2-8-HX-ES SPRING COIL WAS SELECTED FOR ANEURYSM NECK FILLING. THE SPRING COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER, SO ANOTHER SYSTEM WAS REPLACED TO COMPLETE THE OPERATION SMOOTHLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE DISTAL PART OF THE CATHETER. THE COIL HAD COME OUT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624597 ↗
• MalfunctionJul 5, 2024Break; Therapy Delivered to Incorrect Body Area; Stretched; Detachment of Device or Device Component; Break; Therapy Delivered to Incorrect Body Area; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT COIL SEPARATION/BREAK OCCURRED.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT WHEN THE SURGEON USED APB-2-8-HX-ES TO TREAT THE ANEURYSM, FOUND THAT THE PUSH ROD COULD NOT BE PUSHED FORWARD OR RETRIEVED BACKWARD WHEN THE SPRING COIL ENTERED HALF OF THE ANEURYSM. THE SURGEON THOUGHT IT WAS AN ACCIDENTAL STRETCHING, SO HE WITHDREW THE ECHELON MICROCATHETER AS A WHOLE. FINALLY, ABOUT 3CM OF THE COIL REMAINED IN THE BLOOD VESSEL. FOR THE SAFETY OF THE OPERATION, JOHNSON <(>&<)> JOHNSON EP1 STENT WAS USED TO HOLD DOWN THE SPRING COIL, AND THE OPERATION WAS OVER. THE COIL REMAINED IN THE PATIENT AND WAS NOT IMPLANTED AT THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPORTION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCED

  Patient problems: Foreign Body In Patient

  MAUDE report 19679967 ↗
• MalfunctionJan 26, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL WAS FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SPRING COIL STRETCHED UNEXPECTEDLY. 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. NEW INFORMATION RECEIVED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250592 ↗
• MalfunctionOct 31, 2022Break; Stretched; Packaging Problem; Break; Stretched; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS ALREADY STRETCHED WHEN TAKEN OUT OF THE PACKAGE AND COULD NOT BE USED. IT WAS NOTED THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL DID NOT ENTER THE PATIENT'S BODY AND WAS REPLACED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED ANEURYSM LOCATED IN THE RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION THE COIL NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS NOT ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, OR ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER AND STRYKER GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699869 ↗
• MalfunctionAug 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD PREMATURE DETACHMENT. USING THE ALTAS STENT HALF-DEPLOY TECHNOLOGY, AFTER THE ECHELON WAS IN PLACE, AN AXIUM 3*6 3D COIL WAS FILLED IN AND FORMED A HOOP. THE 3*8 ES WAS THEN FILLED IN, AND WHEN IT WAS FILLED TO ABOUT 3/4 OF THE COIL BODY, A COIL OF THE SPRING COIL FANNED INTO THE ANEURYSM-CARRYING ARTERY. IT WAS FOUND THAT WHEN IT WAS WITHDRAWN TO ABOUT 1/2 OF THE COIL BODY, THE PUSH ROD WAS PULLED BACK, AND THE POSITION OF THE SPRING COIL DID NOT CHANGE. THE PUSH ROD HAD NO RESISTANCE, AND THE PUSH ROD WAS PULLED BACK SLOWLY TO CONFIRM THAT THE SPRING COIL WAS AUTOMATICALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE ECHELON 10 POSITION WAS ADJUSTED AND SLOWLY PUSHED THE PUSH ROD, AND MOST PART OF THE DETACHED SPRING COIL WAS PUSHED INTO THE ANEURYSM. THE REMAINING COIL BODY WAS PUSHED OUT OF THE MICROCATHETER BY THE GUIDE WIRE, AND DEPLOYED THE ATLAS STENT TO DEPRESS PART OF THE COIL THAT FANNED INTO THE ANEURYSM-CARRYING ARTERY. THE COIL REMAINS IN PATIENT. IT WAS IMPLANTED AT THE INTENDED LOCATION. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179695 ↗
• MalfunctionMar 30, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO AXIUM COILS COULD NOT BE DETACHED. THE PATIENT WAS BEING TREATED FOR A UNRUPTURED, SACCULAR ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5.28MM AND THE NECK DIAMETER WAS 2.66MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  USING THE MICROCATHETER ECHELON10, BOTH THE COIL BEFORE DELIVERY AND THE COIL AFTER REPLACEMENT COULD BE DELIVERED NORMALLY WITHOUT ANY ABNORMALITY. THE SURGEON JUDGED THAT THE MICROCATHETER WAS NO PROBLEM; DISCARD IT AFTER USE. USING THE MICROCATHETER ECHELON10, IT COULD BE DELIVERED NORMALLY BEFORE DELIVERING THE [APB-2-8-HX-ES] COIL WITHOUT ABNORMALITY; HOWEVER, WHEN IT WAS DELIVERED TO [APB-2-8-HX-ES], THE SPRING COIL WAS DETACHED, AND THE MARKER AND THE MICROCATHETER 2MARKER COULD NOT BE DETACHED AFTER FORMING AN INVERTED T. TRIED 3 TIMES, IT STILL COULD NOT BE DETACHED; THEN REPLACED WITH A [APB-2-8-HX-ES] FOR EMBOLIZATION, THE SAME OPERATION STEPS STILL COULD NOT BE DETACHED, WITHDREW AGAIN; FINALLY REPLACED WITH THE APB-2-4-HX -ES FOR EMBOLIZATION, IT WAS DETACHED SUCCESSFULLY. THE PHYSICIAN ATTEMPTED TO DETA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13951123 ↗
• MalfunctionMar 25, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO AXIUM COILS COULD NOT BE DETACHED. THE PATIENT WAS BEING TREATED FOR A UNRUPTURED, SACCULAR ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5.28MM AND THE NECK DIAMETER WAS 2.66MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  USING THE MICROCATHETER ECHELON10, BOTH THE COIL BEFORE DELIVERY AND THE COIL AFTER REPLACEMENT COULD BE DELIVERED NORMALLY WITHOUT ANY ABNORMALITY. THE SURGEON JUDGED THAT THE MICROCATHETER WAS NO PROBLEM; DISCARD IT AFTER USE. USING THE MICROCATHETER ECHELON10, IT COULD BE DELIVERED NORMALLY BEFORE DELIVERING THE [APB-2-8-HX-ES] COIL WITHOUT ABNORMALITY; HOWEVER, WHEN IT WAS DELIVERED TO [APB-2-8-HX-ES], THE SPRING COIL WAS DETACHED, AND THE MARKER AND THE MICROCATHETER 2MARKER COULD NOT BE DETACHED AFTER FORMING AN INVERTED T. TRIED 3 TIMES, IT STILL COULD NOT BE DETACHED; THEN REPLACED WITH A [APB-2-8-HX-ES] FOR EMBOLIZATION, THE SAME OPERATION STEPS STILL COULD NOT BE DETACHED, WITHDREW AGAIN; FINALLY REPLACED WITH THE APB-2-4-HX -ES FOR EMBOLIZATION, IT WAS DETACHED SUCCESSFULLY. (PLI10) THE PHYSICIAN ATTEMPTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13909797 ↗
• MalfunctionFeb 24, 2022Break; Difficult or Delayed Positioning; Detachment of Device or Device Component; Break; Difficult or Delayed Positioning; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY M1 BIFURCATION. THE MAX DIAMETER WAS 2.5 MM X 2.5 MM. THE NECK DIAMETER WAS 2.3 MM. BLOOD FLOW WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU).  PERFORMED INTRACRANIAL ANEURYSM EMBOLIZATION. UNDER THE GUIDANCE OF THE FATHOM GUIDE WIRE, THE CONVENTIONAL 8F GUIDE CATHETER REACHED THE LEFT COMMON CAROTID ARTERY. THE COAXIAL DISTAL ACCESS CATHETER, STENT CATHETER AND COIL MICROCATHETER ECHELON WERE PLACED AT THE LOCATION OF THE ANEURYSM (THE BIFURCATION OF THE LEFT MIDDLE CEREBRAL ARTERY M1), AND THEN AN EP2 STENT WAS PLACED. IN THE HALF-DEPLOYED STATE OF THE STENT, THE SPRING COIL FILLING WAS STARTED. AFTER FILLING TWO 3-8 (2D) AND ONE 3-6 (3D), THE APB-2-8-HX-ES DETACHABLE COIL WAS IMPLANTED. DURING THE FIRST FILLING, IT WAS NOT EASY TO RETRACT DUE TO THE FILLING POSITION. DURING THE SECOND FILLING, THE COIL WAS AUTOMATICALLY DETACHED IN THE BLOOD VESSEL, AND WAS THEN TAKEN OUT WITH REBAR27 AND SAB-6-20 STENT. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596652 ↗
• MalfunctionJan 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED NO ATTEMPTS HAD BEEN MADE TO DETACH THE COIL WHEN THE PREMATURE DETACHMENT OCCURRED. PART OF THE COIL WAS IMPLANTED IN THE INTENDED POSITION IN THE ANEURYSM AND PART REMAINED OUTSIDE THE ANEURYSM BUT WAS SUCCESSFULLY FIXATED WITH IMPLANTATION OF THE SOLITAIRE AB STENT. IT WAS NOTED THAT A PART OF THE COIL WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307757 ↗
• MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED ANCILLARY DEVICES: ECHELON10 MICROCATHETER 105-5091-150 LOT: B232110, 5FNAVIEN INTERMEDIATE CATHETER, SYNCHRO-14 GUIDE WIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13044338 ↗