AxiumTM APB-3-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00847536021228), received between Nov 28, 2018 and Jan 28, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (16 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL BECAME HARD RAPIDLY AND HAD EXTENSION TO THE EMBOLIZATION COIL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (A-COM) WITH A MAX DIAMETER OF 4.5MM AND A 3.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS NO ABNORMALITIES. IT WAS REPORTED THAT, "THE 3RD PRIME COIL THAT WAS INSERTED WAS ABOUT 1 CM AWAY AND BECAME HARD RAPIDLY, SO IT WAS COLLECTED. IT IS PRESUMED TO BE BROKEN." IT WAS NOTED THAT THERE WAS COIL EXTENSION TO THE EMBOLIZATION COIL AND THE COIL WAS NOT REPOSITIONED. THERE WAS NOT RESISTANCE DURING THE PREPARATIONS OR USE. THE DEVICE WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THE EVENTS THE PRODUCT WAS NOT USED IN AN INFECTED PATIENT. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A RIST 6F GUIDING CATHETER, PHENOM17 MICROCATHETER, AND A NON-MEDTRONIC (SYNCHRO) GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203409 ↗
• MalfunctionApr 28, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT WHEN DETACHING THE COIL, THE REAR END OF THE DELIVERY PUSHER WAS INSERTED INTO THE SLOT OF THE INSTANT DETACHER, BUT RESISTANCE WAS ENCOUNTERED, AND IT COULD NOT BE INSERTED SUFFICIENTLY. NORMAL DETACHMENT WAS PERFORMED UNTIL INSERTION WAS POSSIBLE, HOWEVER, DETACHMENT WAS NOT POSSIBLE, SO THE COIL WAS DETACHED BY FORCE DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANCE DETACHER 2 TIEMS. THE PHYSICIAN DID TO ATTEMPT TO USE ANOTHER INSTANT DETACHER. THERE WAS ATTEMPT TO DETACH THE DEVICE WITH HYPOTUBE. THERE WERE DEFECTS WIT HTHE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE BASIL ARTERY TIP. THE MAX DIAMETER WAS 9.0MM AND THE NECK DIAMETER WAS 6.0MM. BLLOD FLOW SPEED WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922532 ↗
• InjuryNov 12, 2024Difficult or Delayed Positioning; Unintended Movement; Migration; Physical Resistance/Sticking; Difficult or Delayed Positioning; Unintended Movement; Migration; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE ANEURYSM RUPTURE WAS TREATED WITH PLACEMENT OF ADDITIONAL COILS UNTIL NO FURTHER EXTRAV ASATION WAS OBSERVED. THE VESSEL WAS NOT PERFORATED. THE ANEURYSM WAS PERFORATED. RESISTANCE WAS BELIEVED TO BE CAUSED BY THE STENT IN THE PARENT VESSEL TRAPPING THE MICROCATHETER AGAINST THE VESSEL WALL SO COIL RESISTANCE COULD NOT BE FELT PROPERLY. THE DOCTOR DID HAVE A FAIR AMOUNT OF FORWARD LOAD ON THE MICROCATHETER BECAUSE OF THE ACUTE ANGLE INTO THE ANEURYSM. NO RESISTANCE WAS FELT WHILE ADVANCING THE COIL. RESISTANCE WAS FELT WITH DEPLOYING THE COIL INTO THE ANEURYSM. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THERE WAS NO DAMAGE TO THE PHENOM CATHETER.

  Patient problems: Perforation of Vessels; Rupture

  MAUDE report 20666388 ↗
• MalfunctionJun 12, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS SELECTED FOR THE FIRST COIL WHEN TREATING A CEREBRAL ANEURYSM (ICA-PARACLINOID) OF 5 MM WITH A COIL EMBOLIZATION (STENT CONCOMITANT). AFTER THE AXIUM COIL WAS INSERTED INTO THE CEREBRAL ANEURYSM, THE DETACHER OF THE PRODUCT WAS USED FOR DETACHMENT (5 TIMES OR MORE), BUT IT COULD NOT BE DETACHED. ATTEMPTS OF DETACHMENT WERE MADE USING THE SECONDARY DETACHMENT MECHANISM, HOWEVER, THE DETACHMENT WAS NOT ACHIEVED, SO IT WAS DETERMINED THAT CONTINUED USE WOULD BE DIFFICULT AND THE DEVICE WAS COLLECTED. FACILITY'S VIEW, THE PRODUCT IS RECOGNIZED AS DEFECTIVE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519417 ↗
• MalfunctionApr 17, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN WANTED TO TREAT THE ANEURYSM WITH AXIUM COILS. HE INSERTED THE FIRST COIL INTO THE ANEURYSM WITHOUT ANY FRICTION OR PROBLEMS. HE USED THE INSTANT DETACHER TO DETACH THE COIL AS DESCRIBED IN THE IFU; HOWEVER, THE COIL WAS NOT DETACHED. HE USED ANOTHER INSTANT DETACHER, BUT THE COIL WAS NOT DETACHED. HE DID THE "PLAN B" AND BROKE THE PUSHER WIRE PROXIMAL TO DETACH THE COIL, BUT THE COIL WAS NOT DETACHED. FINALLY, HE REMOVED THE WHOLE COIL OUT OF THE BODY WITHOUT ANY PROBLEMS. HE FINISHED THE PROCEDURE WITH OTHER AXIUM COILS. THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER ONE TIME. THE PHYSICIAN ATTEMPTED TO DETACH WITH ANOTHER INSTANT DETACHER ONE TIME. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE ONE TIME. THE DEVICE AND ANY ACCESSORIES 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 AN M3 ANEURYSM. ANCILLARY DEVICES INCLUDE A ENVOY 6F GUIDE CATHETER, ECHELON 10 45GRAD MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19129188 ↗
• MalfunctionApr 3, 2024Break; Separation Failure; Detachment of Device or Device Component; Material Deformation; Break; Separation Failure; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT COULD NOT BE DETACHED WITH THE DETACHER, SO IT WAS UNRAVELED. THERE WAS COIL SEPARATION /BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE BODY AND COLLECTED WITH THE MICROCATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. 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 RIGHT IC-PC ANEURYSM WITH A MAX DIAMETER OF 8MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033151 ↗
• MalfunctionApr 26, 2023Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815220 ↗
• MalfunctionNov 14, 2022Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  (B)(6) 2022 MPXR 998727, VIDEO1, (FOR, REP, HCP): COIL DETACHMENT FAILURE AND A STRETCHED PUSH WIRE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM 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 MODERATE. IT WAS REPORTED THE AXIUM COIL WAS SELECTED AS THE FIRST COIL, PREPARED AS PER THE PACKAGE INSERT, DELIVERED INTO THE SL10 MICROCATHETER, AND COILED INSIDE THE ANEURYSM. IT WAS REWOUND ABOUT 5-6 TIMES UNTIL THE FRAME WAS FORMED AS DESIRED. AFTER IT WAS REWOUND SEVERAL TIMES TO FORM AN IDEAL FRAME, IT WAS DETACHED USING A DETACHER AS PER THE PACKAGE INSERT. WHEN THE PUSH-WIRE OF THE COIL WAS COLLECTED, IT WAS FOUND THAT THE AXIUM COIL WAS NOT CUT AND CAME WITH IT. AFTERWARD, IT WAS RE-DELIVERED INTO THE ANEURYSM, THEN THE BREAK INDICATOR WAS BROKEN, AND THE SECONDARY DETACHMENT OPERATION WAS PERFORMED. IT WAS DETERMINED THAT THE DETACHER WAS BEING USED FOR DETACHMENT AS PER THE PACKAGE INSERT. THE DISTAL END OF THE PUSH WIRE WAS STRETCHED. THE BREAK INDICATOR, WHICH IS THE SECONDARY DETACHMENT MECHANISM, WAS BROKEN, AND THE RELEASE WIRE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789176 ↗
• MalfunctionNov 2, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL BECAME PRE-MATURELY DETACHED INSIDE THE MICROCATHETER. THE CATHETER WAS REMOVED AND ANOTHER COIL WAS USED. COIL SEPARATION/BREAK AND PREMATURE DETACHMENT OCCURRED. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING THE DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE 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 LEFT PCA ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE AN ENBOY 6F GUIDE CATHETER, HEADWAY17 MICROCATHETER, AND A SNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715241 ↗
• MalfunctionApr 26, 2022Difficult or Delayed Positioning; Separation Failure; Detachment of Device or Device Component; Difficult or Delayed Positioning; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL DETACHED IN THE CATHETER AFTER BEING UNABLE TO BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED USING THE INSTANT DETACHER, SO AN EMERGENCY SEPARATION WAS ALSO ATTEMPTED, BUT THIS ALSO DID NOT WORK. TWO ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND 4 MANUAL ATTEMPTS WERE MADE. A SECOND INSTANT DETACHER WAS NOT USED. THE COIL WAS "TURNED TO BE SHAKEN OFF" WHEN THE CATHETER WAS INSERTED AND RETRACTED. THE COIL WAS ABLE TO BE PLACED IN THE TARGET POSITION IN THE ANEURYSM. IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO POSITION. THE COIL DID NOT JUMP DURING PLACEMENT, THERE WAS NO VASCULAR DAMAGE, THE TIP OF THE CATHETER WAS NOT UNDER STRESS, THE TIP OF THE CATHETER WAS NOT MOVED DURING DEPLOYMENT, AND THE PUSHER WAS NOT ROTATED INSIDE THE BODY. THE ANEURYSM DID NOT RUPTURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14211751 ↗
• MalfunctionMar 30, 2022Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS BROKEN AND COULD NOT BE DETACHED. IT WAS UNKNOWN HOW MANY DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND THE MANUAL METHOD. A SECOND INSTANT DETACHER WAS NOT USED. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953924 ↗
• MalfunctionJan 24, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT FIRST THERE WAS A DETACHMENT DEFECT WITH AN AXIUM COIL. THE EVENT WAS AT THE SEPARATION POINT OF DELIVERY PUSHER AND COIL SUSPECTED TO BE BROKEN, DETACHMENT HAPPENED. AFTER THAT RESISTANCE WAS FELT IN THE DISTAL REGION FROM THE MIDDLE OF THE HEADWAY17. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS IN THE PACKAGE. THERE WAS A DETACHMENT DEFECT DURING INSERTION OF PRIMEFRAME 3.5-6 FROM HEADWAY17, BUT INSERTION WAS DONE. AFTER THAT, WHEN INSERTING THE AXIUM, RESISTANCE WAS FELT. THE COIL WAS COLLECTED. WHEN INSERTING THE FLUSH/GUIDEWIRE THERE WAS A TANGLED FEELING AT THE SAME POINT BUT SINCE IT PASSED THROUGH, AXIUM WAS RE-INSERTED AGAIN, IT COULD NOT BE INSERTED AT ALL AND WAS COLLECTED. BASED ON THE EVENT, A DEFECT IN THE LUMEN OF THE HEADWAY17 MAY HAVE BEEN CAUSED, NOT BY A DEFECT CAUSED BY AXIUM, BUT SINCE THE PRIMEFRAME 3.5-6 WAS IMPLANTED AND THE COIL'S CONDITION COULD NOT BE CONFIRMED. THE COIL WAS STUCK IN THE CENTER AND DISTAL SECTIONS OF THE CATHETER. THE CATHETER WAS DAMAGED IN THE SHAFT CENTER, THERE WAS NO DAMAGE TO THE COIL SYSTEM. ANCILLARY DEVICES: HEADWAY17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339402 ↗
• MalfunctionSep 8, 2021Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DETACHED EARLY AND DEVIATED FROM THE ANEURYSM. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING (I C-PCOM) ANEURYSM. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE FOURTH COIL WAS PLACED THERE WAS A SLIGHT DEVIATION FROM THE OUTSIDE OF THE ANEURYSM. INSERTION WAS COMPLETED AFTER INSERTING AND REMOVING IT TWICE. THE COIL WAS APPROPRIATELY DETACHED WITH A DETACHER, BUT WHEN THE DELIVERY PUSHER WAS PULLED OUT, IT WAS SUSPECTED TO BE STRETCHED. THE MICROCATHETER WAS ALSO REMOVED ON THE ASSUMPTION THAT SOMETHING REMAINED IN THE MICROCATHETER; HOWEVER, THE THIRD COIL DEVIATED FROM THE ANEURYSM SO IT WAS COLLECTED WITH A SNARE. THERE WAS COIL DAMAGE/EARLY DETACHMENT. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTIONS WERE NEEDED. THERE WAS NO DAMAGE TO THE DELIVERY PUSHER, AND THERE HAD BEEN NO RESISTANCE DURING DELIVERY. THE COIL HAD BEEN REPOSITIONED TWICE, AND NO DETACHMENT ATTEMPTS WERE MADE. THE PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY. A CONTINU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439557 ↗
• MalfunctionJun 28, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DETACHMENT PROCEDURE WAS NOT PERFORMED BECAUSE THE COIL AND PUSHER WIRE STOPPED ADVANCING IN THE MIDDLE OF BEING INSERTED INTO THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075992 ↗
• MalfunctionApr 20, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2.5MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT WHEN THE DOCTOR ATTEMPTED TO DETACH THE COIL IT COULD NOT BE CUT EVEN WHEN THE DETACHER WAS USED TWICE. AFTERWARDS, AN EMERGENCY DETACHMENT WAS ATTEMPTED, BUT IT COULD NOT BE DETACHED. TWO ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE MANUALLY. THERE WERE NO PROBLEMS WITH THE INSTANT DETACHER. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697835 ↗
• MalfunctionApr 12, 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 AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 2.7MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COIL WAS ACCIDENTALLY DETACHED DURING USE, BUT WAS IMPLANTED IN THE INTENDED LOCATION. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. THE COIL PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, AND THE PHYSICIAN HAD NOT REPOSITIONED THE COIL. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHWIRE DURING THE PROCEDURE, AND 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 11651690 ↗
• MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS PULLED AND INSERTED SEVERAL TIMES WHILE IMPLANTING THE COIL, AND IT HAD DETACHED UNEXP ECTEDLY. AFTERWARDS, THE COIL WAS COLLECTED AND REMOVED FROM THE PATIENT'S BODY USING A SNARE. THERE WAS NO DAMAGE TO OR ROTATION OF THE DELIVERY PUSHWIRE, NO RESISTANCE WAS EXPERIENCED, NO DETACHMENT ATTEMPTS WERE MADE, THE DEVICE DID NOT JUMP DURING IMPLANTATION, AND IT WAS UNKNOWN IF A CONTINUOUS FLUSH HAD BEEN USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING (PCOM) ARTERY WITH SUBARACHNOID HEMORRHAGE (SAH) WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE UNKNOWN. ANCILLARY DEVICES INCLUDE A TERUMO 8F SHEATH, FUBUKI 8F GUIDECATHETER, SL-10 MICROCATHETER, CHIKAI GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243882 ↗
• MalfunctionDec 1, 2020Use of Device Problem; Separation Failure; Detachment of Device or Device Component; Use of Device Problem; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD A DETACHMENT ISSUE AND THE RELEASE WIRE BROKE. THE PATIENT WAS BEING TREATED FOR A RUPTURED SACCULAR ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY (ACOM) WITH SUBARACHNOID HEMORRHAGE. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED THROUGH THE MICROCATHETER WITH NO RESISTANCE FELT DURING DELIVERY. THE COIL WAS IMPLANTED AS INTENDED IN THE ANEURYSM. AN ATTEMPT WAS MADE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) BUT WAS NOT SUCCESSFUL THOUGH THE ID WAS NEW. AN ATTEMPT WAS THEN MADE TO DETACH THE COIL BY MANUAL METHOD. HOWEVER, WHEN THE BREAK INDICATOR WAS BROKEN AND THE MANUAL DETACHMENT METHOD WAS PERFORMED, THE RELEASE WIRE THAT SHOULD APPEAR FROM THE BREAK INDICATOR PART WAS TORN, AND THE RELEASE WIRE WAS PHYSICALLY BROKEN. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT'S BODY. THE COIL WAS REPLACED WITH A NON-MEDTRONIC PRODUCT AND THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928264 ↗
• MalfunctionFeb 13, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME FAILED TO DETACH WITH THE INSTANT DETACHER AND VIA THE MANUAL METHOD. THE COIL WAS RETRIEVED WITHOUT BEING DETACHED BECAUSE THE RELEASE WIRE MIGHT HAVE BEEN TORN. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED. 2 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND 2 ADDITIONAL ATTEMPTS WERE MADE WITH A SECOND INSTANT DETACHER. ONE MANUAL DETACHMENT WAS MADE. THIS EVENT OCCURRED DURING THE TREATMENT OF RIGHT INTERNAL CAROTID (IC), UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 5 MM WITH A NECK OF 3 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707244 ↗
• InjuryAug 19, 2019Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  MEDTRONIC RECEIVED REPORT THAT THE ARIUM PRIME COIL WAS DELIVERED INTO THE ANEURYSM AND WAS REPOSITIONED SEVERAL TIMES, BEFORE DETACH ATTEMPTING TO DETACH THE COIL AND AFTER FORMING THE FRAME, THE COIL STOPPED RESPONDING. THE PUSHWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM. AFTER THAT, WHEN THE BALLOON WAS DEFLATED, THE COIL MASS MOVED SLIGHTLY. A SECOND COIL WAS USED AND WAS DELIVERED INSIDE THE CATHETER, THE CATHETER MOVED SLIGHTLY. AT THAT TIME THE BALLOON WAS DEFLATED, HOWEVER, THE CATHETER TOUCHED THE ANEURYSM WALL, ONCE THE BALLOON WAS DEFLATED, AND WHEN ANGIOGRAPHY WAS PERFORMED, THE DETACHED COIL COMPLETELY DEVIATED TO THE PARENT BLOOD VESSEL, AND IT WAS RETRACTED WITH THE SNARE. THIS EVENT OCCURRED THE TREATMENT OF A RIGHT DISTAL M1, UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 3MM AND THE NECK WAS 2MM. THE ANATOMY WAS REPORTED TO BE NORMAL IN TORTUOSITY. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906949 ↗
• MalfunctionJul 8, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS DELIVERED INTO THE ANEURYSM, AND AN ATTEMPT WAS MADE TO DETACH THE COIL WITH THE DETACHER, BUT IT FAILED. THE DOCTOR ATTEMPTED TWICE TO DETACH THE COIL USING THE INSTANT DETACHER. THEY DID NOT ATTEMPT TO DETACH THE COIL WITH ANOTHER INSTANT DETACHER. THE MANUAL DETACHMENT METHOD WAS PERFORMED, BUT IT FAILED ALSO. ONE ATTEMPT WAS MADE TO DETACH MANUALLY WITH THE HYPOTUBE. THE COIL KEPT COMING OFF WITH THE DELIVERY PUSHER WITHOUT DETACHING. THE COIL WAS SLOWLY DRAWN INTO THE CATHETER AND REMOVED TOGETHER WITH THE MICROCATHETER. THE COIL WAS DETACHED IN THE MICROCATHETER. THERE WERE NO PROBLEMS WITH THE USAGE OF THE DETACHER AND THE METHOD OF MANUAL DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A RUPTURED, SACCULAR ANEURYSM LOCATED AT THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF OVER 10MM AND A NECK DIAMETER OF OVER 4MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED/FLUSHED AS INDICATED IN THE IFU. THERE WAS NO RESISTANCE DURING DELIVERY. THE PATIENT WAS ULTIMATELY TREATED WITH A COMPETITOR COIL. NO DAMAGE WAS SEEN ON THE DEVICES. ANCILLARY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8768867 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLEX WITH SHIELD (PED2) WERE USED TO RE-TREAT A NECK RECURRENCE (2 X 3 X 3MM) OF A RUPTURED AND COILED PCOMA-ANEURYSM (INITIALLY 8X5X4,5 MM).

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8744819 ↗
• MalfunctionApr 8, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL WOULD NOT DETACH USING THE INSTANT DETACHER OR BY THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE). THE IMPLANT COIL EVENTUALLY DETACHED AFTER THE PHYSICIAN PUSHED AND PULLED THE DETACHMENT COIL SEVERAL TIMES AND PUSHED THE COIL INTO THE ANEURYSM WITH THE DELIVERY PUSHER. THE IMPLANT COIL IMPLANTED IN THE PATIENT. THE PATIENT¿S VASCULATURE WAS MEDIUM IN TORTUOSITY AND THE SIZE OF THE ANEURYSM WAS 3MM. INSTANT DETACHER WAS BRAND NEW OUT OF BOX. THERE WAS NOT ANY DIFFICULTY OR FRICTION DURING PROCEDURE. THE PHYSICIAN DID SEVERAL TIMES REPOSITION THE COILS. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHWIRE DURING PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490159 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL NON-DETACHMENT DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A 2.5MM AND 3MM TANDEM ANEURYSM IN THE IC-ANCH. THE PATIENT¿S VASCULATURE WAS UNKNOWN. IT WAS REPORTED THAT DURING THE PROCEDURE, THE MICROCATHETER (HEADWAY) WAS PLACED IN THE ANEURYSM. IT WAS REPORTED THAT THE COIL WAS ATTEMPTED TO BE DETACHED WITH THE INSTANT DETACHER 2-3 TIMES AND USING THE MANUAL METHOD WITHOUT SUCCESS. NO FORCE WAS APPLIED DURING THE USE OF THE DEVICES. THE COIL WAS RETRIEVED, BUT AFTER MOVING THE DEVICE 1.5CM, THE COIL DETACHED. THE IMPLANT COIL WAS PUSHED INTO THE ANEURYSM WITH THE GUIDEWIRE. THERE WAS NO NOTABLE DAMAGE TO THE DEVICES. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445323 ↗
• MalfunctionMar 14, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED DETACH WITH THE INSTANT DETACHER (ID). THE DETACHMENT ATTEMPT WITH THE ID WAS MADE 4 TIMES WITHOUT SUCCESS. MANUAL DETACHMENT WAS ATTEMPTED 2 TIMES, ALSO WITHOUT SUCCESS. THE COIL WAS REPORTED NOT TO HAVE BEEN IMPLANTED. THE COIL WAS REPORTED AS BEEN DISCARDED AT THE SITE. THIS EVENT OCCURRED DURING THE TREATMENT OF A UNRUPTURED, AMORPHOUS ANEURYSM. THE BLOOD FLOW AND THE ANATOMY WERE REPORTED TO BE NORMAL. NO PATIENT INJURY REPORTED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ANCILLARY DEVICES WERE DISCARDED AT THE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422986 ↗