Axium Prime Detachable Coil System APB-1.5-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000313647), received between Mar 10, 2022 and Aug 13, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237610 ↗
• MalfunctionJun 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION OF AN ANEURYSM, AFTER THE MICROCATHETER WAS POSITIONED, A JOHNSON <(>&<)> JOHNSON 2.5¿5 COIL WAS SELECTED AND SUCCESSFULLY PUSHED IN. SUBSEQUENTLY, ANOTHER COIL OF THE SAME BRAND WAS SELECTED, BUT IT COULD NOT BE ADVANCED INTO THE MICROCATHETER. OTHER COILS, INCLUDING AXIUM PRIME (APB-1.5-2-3D-ES, APB-1.5-2-3D-ES, APB-1.5-3-3D-ES) AND SEVERAL OTHER BRANDS, WERE ATTEMPTED, BUT NONE OF THEM COULD BE PUSHED IN. THE PHYSICIAN WITHDREW THE COILS. THE MICROCATHETER WAS THEN REMOVED AND REPLACED WITH A NEW ONE, AFTER WHICH THE PROCEDURE WAS COMPLETED. RESISTANCE OCCURRED AT THE HUB OF THE CATHETER. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THE AXIUM COILS DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666188 ↗
• MalfunctionJun 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION OF AN ANEURYSM, AFTER THE MICROCATHETER WAS POSITIONED, A JOHNSON & JOHNSON 2.5¿5 COIL WAS SELECTED AND SUCCESSFULLY PUSHED IN. SUBSEQUENTLY, ANOTHER COIL OF THE SAME BRAND WAS SELECTED, BUT IT COULD NOT BE ADVANCED INTO THE MICROCATHETER. OTHER COILS, INCLUDING AXIUM PRIME (APB-1.5-2-3D-ES, APB-1.5-2-3D-ES, APB-1.5-3-3D-ES) AND SEVERAL OTHER BRANDS, WERE ATTEMPTED, BUT NONE OF THEM COULD BE PUSHED IN. THE PHYSICIAN WITHDREW THE COILS. THE MICROCATHETER WAS THEN REMOVED AND REPLACED WITH A NEW ONE, AFTER WHICH THE PROCEDURE WAS COMPLETED. RESISTANCE OCCURRED AT THE HUB OF THE CATHETER. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THE AXIUM COILS DID NOT E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666174 ↗
• MalfunctionApr 9, 2026Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE OUTER PACKAGING SEAL OF THIS COIL WAS INTACT; HOWEVER, AFTER IT WAS STOCKED INTO INVENTORY AND OPENED, IT WAS FOUND THAT THE INNER PACKAGING WAS NOT STERILIZED AND SEALED. THE EQUIPMENT DEPARTMENT REQUESTED THAT IT BE RETURNED TO THE MANUFACTURER, BELIEVING THAT IT COULD NOT BE CONFIRMED WHETHER THE DEVICE WAS STERILE-PACKAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836498 ↗
• MalfunctionApr 2, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN THE DISTAL SECTION OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED ANEURYSM OF THE MIDDLE CEREBRAL ARTERY. IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT ANGIOGRAPHY, HEMORRHAGE FROM A MIDDLE CEREBRAL ARTERY ANEURYSM WAS IDENTIFIED. AFTER ESTABLISHING VASCULAR ACCESS, THE MICROGUIDEWIRE WITH MICROCATHETER WERE ADVANCED INTO THE ANEURYSM, AND A 5-15 COIL WAS FILLED FOR FORMING THE HOOP. SEVERAL ADDITIONAL COILS WERE DELIVERED, BUT WHEN ATTEMPTING TO DELIVER THE APB-1.5-2-3D COIL, IT WAS DELIVERED INTO THE MICROCATHETER, BUT COULD NOT BE ADVANCED OUT OF IT. DESPITE MULTIPLE ATTEMPTS, THE COIL STILL COULD NOT BE ADVANCED OUT OF THE MICROCATHETER. THE CATHETER WAS NOT DAMAGED. TO ENSURE PROCEDURAL SAFETY, A NEW COIL WAS USED FOR EMBOLIZATION, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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. THE CAUSE OF THE RESISTANCE WAS DETERMINED TO BE THAT THE COIL WAS UNDELIVERABLE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767387 ↗
• MalfunctionFeb 5, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE LESION LOCATION WAS THE ANTERIOR COMMUNICATING ARTERY. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. COIL EMBOLIZATION WAS PERFORMED, WITH THE APB-1.5-2-3D-ES SELECTED FOR FINISHING. THE COIL WAS ADVANCED INTO THE ANEURYSM BUT COULD NOT BE DETACHED. THE COIL WAS THEN REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272080 ↗
• MalfunctionFeb 3, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A AXIUM COIL QC-6-20-3D-CN BECAME STUCK IN A ECHELON CATHETER AND AN AXIUM COIL APB-1.5-2-3D-ES COULD NOT BE DETACHED NORMALLY. IT WAS REPORTED THAT A QC-6-20-3D-CN SPRING COIL WAS USED FOR ANEURYSM TREATMENT. AFTER HYDRATION, IT WAS DELIVERED INTO THE ECHELON10 MICROCATHETER. DURING DELIVERY WITHIN THE MICROCATHETER, THE COIL BECAME STUCK AND COULD NOT REACH THE ANEURYSM. IT HAD TO BE REMOVED. IT WAS NOTED THAT THE COIL WAS STUCK IN THE DISTAL SECTION OF THE CATHETER. THERE WAS NO REPORTED DAMAGED TO THE CATHETER OR THE COIL. APB-1.5-2-3D-ES SPRING COIL WAS INTENDED FOR ANEURYSM TREATMENT. AFTER HYDRATION, IT WAS DELIVERED INTO THE ANEURYSM USING THE ECHELON MICROCATHETER. DURING DETACHMENT, THE COIL COULD NOT BE DETACHED NORMALLY. THE OPERATOR REPORTED THAT BOTH MANUAL DETACHMENT AND DETACHMENT DEVICE METHODS WERE ATTEMPTED, BUT DETACHMENT WAS STILL UNSUCCESSFUL. IT WAS NOTED THAT APB-1.5-2-3D-ES HAD NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH ONLY 1 INSTANT DETACHER 5-6 TIMES. THE PHYSICIAN ALSO ATTEMPTED A MANUAL DETACHMENT VIA THE HYPOTUBE 2 TIMES. THERE WAS NO REPORTED ISSUES WITH THE INSTANT DETACHER. IT WAS INDICATED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247885 ↗
• MalfunctionJan 16, 2026Separation Failure; Detachment of Device or Device Component; Migration

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS IN THE ANTERIOR CEREBRAL ARTERY (ACA). VESSEL TORTUOSITY WAS NORMAL. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE REPORTED AXIUM ISSUE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. MORE THAN TWO INSTANT DETACHERS (ID-1-5) WERE USED. FOR DEVICE APB-2.5-4-3D-ES, ALTHOUGH THERE WAS AN INITIAL NON-DETACHMENT, THE DEVICE WAS EVENTUALLY DETACHED AFTER SEVERAL ATTEMPTS USING THE BACKUP DETACHMENT METHOD. FOR DEVICE APB-1.5-2-3D-ES, THE COIL WAS ALSO EVENTUALLY DETACHED AFTER SEVERAL ATTEMPTS USING THE BACKUP DETACHMENT METHOD; HOWEVER, DETACHMENT OCCURRED AT AN UNINTENDED TIME, RESULTING IN MIGRATION OF THE DEVICE TO AN UNINTENDED LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24093251 ↗
• MalfunctionJul 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  AN APB-1.5-2-3D-ES WAS RETURNED WITHOUT ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542195 ↗
• InjuryFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENT ATTEMPTS WERE MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS IMPLANTED, BUT WAS NOT IN THE INTENDED LOCATION. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AS IT WAS PRESSED WITH A STENT TO STICK IT TO THE WALL. TWO COILS HAD BEEN IMPLANTED BEFORE AND AFTER THE COIL MALFUNCTIONED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434361 ↗
• MalfunctionDec 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930290 ↗
• InjuryOct 23, 2024Detachment of Device or Device Component; Material Deformation; Unintended Movement; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND THERE WAS CATHETER KICKBACK. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 1.78MM, AND THE NECK DIAMETER WAS .75MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT 8F VASCULAR SHEATH WAS USED TO PUNCTURE THROUGH THE FEMORAL ARTERY. WITH THE SUPPORT OF THE 0.035 LOACH GUIDEWIRE AND THE GUIDE-CATHETER, THE DELIVERY CATHETER WAS INTRODUCED INTO THE C1 SEGMENT OF THE INTERNAL CAROTID ARTERY. THE LOACH GUIDEWIRE AND THE GUIDE-CATHETER WERE WITHDRAWN. THE 0.014 GUIDEWIRE GUIDED THE 0.017 MICROCATHETER ECHELON 10 TO THE C7 SEGMENT, AND THE INTRACRANIAL SUPPORT CATHETER REACHED THE C5 OF THE INTERNAL CAROTID ARTERY THROUGH THE MICROCATHETER. THE 0.014 MICRO-GUIDEWIRE WAS GUIDED TO THE ANEURYSM NECK OF THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY, AND THE MICROCATHETER WAS GUIDED TO THE ANEURYSM NECK OF THE A2 SEGMENT THROUGH THE MICRO-GUIDEWIRE. THE DETACHABLE COIL WAS DELIVERED TO THE ANEURYSM NECK THROUGH THE MICROCATHETER. THE DETACHABLE COIL CAME OUT OF THE MICROCATHETER TO FO

  Patient problems: Cognitive Changes; Ischemia Stroke; Obstruction/Occlusion; Vasoconstriction

  MAUDE report 20518481 ↗
• MalfunctionJul 9, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER DURING THE DELIVERY PROCESS, AND IT WAS WITHDRAWN FROM THE BODY AND FOUND THAT IT HAD STRETCHED. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED ON THE CATHETER. THE IMPLANT COIL WAS DAMAGED. 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, UNRUPTURED LEFT POSTERIOR COMMUNICATING SEGMENT ANEURYSM WITH A MAX DIAMETER OF 4.7MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A COOK6 SHEATH, NAVIEN 5F GUIDE CATHETER, MICROVENTION, HEADWAY 17 MICROCATHETER, SYNCHRO2 GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19703879 ↗
• MalfunctionMay 10, 2024Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN WANED TO REMOVE THE (LAST) COIL, BECAUSE IT WAS NOT OPTIMAL IN PLACE. WHILE PULLING THE PUSHER WIRE, THE COIL DIDN¿T MOVE, SO IT WAS ALREADY DETACHED WITHOUT THE DETACH MECHANISM. THERE WAS COIL PREMATURE DETACHMENT. THE COIL REMAINED IN THE PATIENT AND WAS IMPLANTED AT THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO Y FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL ONE TIME. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL.  THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. 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 A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A SL-10 STR  MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286514 ↗
• MalfunctionMay 7, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN THE CATHETER AND HAD STRETCHED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 2 MM, NECK DIAMETER 2 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL AND BLOOD FLOW WAS NORMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY (7 MM). AFTER THE MICROCATHETER WAS HYDRATED AND PLASTICIZED NORMALLY, IT REACHED THE LOCATION OF THE LESION. AFTER THE AXIUM COIL WAS HYDRATED, IT WAS FILLED. AFTER A PART OF THE SPRING COIL ENTERED THE MICROCATHETER, IT COULD NO LONGER ENTER AFTER MULTIPLE ADJUSTMENT AT TEMPTS. THE COIL COULD NOT BE RETRACTED AND WAS STUCK IN THE MICROCATHETER. AFTER MANY EFFORTS OUTSIDE THE BODY, THE COIL HAD STRETCHED WHEN IT WAS WITHDRAWN, AND THE MICROCATHETER COULD NO LONGER BE USED. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE COMPLETED BY REPLACING THE MICROCATHETER AND SPRIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264262 ↗
• MalfunctionFeb 8, 2024Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH AND THEN DETACHED UPON REMOVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE C6 WITH A MAX DIAMETER OF 2.5 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON PERFORMED ANEURYSM EMBOLIZATION. AFTER THE MICROCATHETER WAS IN PLACE, THE FIRST SPRING COIL WAS SELECTED AS APB-2-4-3D-ES, AND THE FILLING WAS SMOOTH. CHOSE APB-1.5-2-3D-ES FOR THE SECOND RING, IT COULD NOT BE DETACHED AFTER FILLING IN THE SPRING COIL. REPEATEDLY ADJUSTING THE ANGLE OF THE MICROCATHETER STILL FAILED TO DETACH. THEN IT WAS WITHDRAWN FROM THE BODY, AND THE SPRING COIL WAS TORN OFF DURING THE PROCESS OF WITHDRAWING FROM THE BODY. THE MICROCATHETER WAS QUICKLY REMOVED AND THE COIL WAS TAKEN OUT TOGETHER, ENDING THE SURGERY. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A 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 INST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669654 ↗
• MalfunctionDec 28, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS 1 COIL IMPLANTED BEFORE AND 2 COILS IMPLANTED AFTER THIS MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414228 ↗
• MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE. THERE WAS NO KINK/D AMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957433 ↗
• MalfunctionAug 31, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT COIL RESISTANCE/STUCK IN SHEATH AND COIL STRETCH OCCURRED. IT WAS REPORTED THAT THE SURGEON DELIVERED THE THIRD PRIME 1.5*2 3D COIL FROM THE ECHELON MICROCATHETER ACCORDING TO THE STANDARD PROCEDURE, AND FOUND RESISTANCE AT THE INTRODUCTION SHEATH AND THE Y VALVE, SO WITHDREW IT TO CHECK, FOUND THAT THE COIL HAD BEEN STRETCHED, AND ASKED TO RETURN TO THE FACTORY FOR INSPECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE MIDDLE CEREBRAL 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 MODERATE. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. IT WAS UNKNOWN IF THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661192 ↗
• MalfunctionJun 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STUCK IN THE CATHETER IN THE PROXIMAL SECTION. THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER WAS NOT DAMAGED AND IT WAS UNKNOWN IF THE COIL WAS DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NO PATIENT INVOLVED IN THE EVENT. ANCILLARY DEVICES INCLUDE AN ENBOY 7F GUIDE CATHETER, HEADWAY17 MICROCATHETER, AND SYNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239685 ↗
• MalfunctionMar 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A MIDDLE MENINGEAL ARTERY COIL EMBOLIZATION PROCEDURE TO TREAT A SUBDURAL HEMATOMA. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. 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. DURING DEPLOYMENT, THE PHYSICIAN DETERMINED THAT THE COIL HAD BECOME DETACHED. IT WAS NOTED THAT THE COIL PUSHWIRE MAY HAVE BEEN BENT DURING OPENING OF THE PACKAGE OR PUSHING THE WIRE. THERE WAS NO FRICTION OR OTHER DIFFICULTY NOTED DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE PUSHER DURING THE PROCEDURE. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. THE MICROCATHETER AND COIL WERE REMOVED TOGETHER. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE COIL WAS REPLACED WITH ANOTHER AXIUM COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505587 ↗
• MalfunctionSep 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN TRYING TO GO THROUGH THE INTRODUCER SHEATH (THE PLASTIC PROTECTOR), THE COIL WAS CLOGGED SO THE COIL WIRE COULDN'T GO THROUGH IT. THE COIL WAS REPLACED, AND THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. AFTER PROCEDURE THEY TRIED TO GO THROUGH IT AGAIN, AND THE COIL WIRE COULD PASS WITH STRONG PRESSURE AND SEVERAL TRIALS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450057 ↗
• MalfunctionJul 12, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT COIL. 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 ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987336 ↗
• MalfunctionMar 10, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PRIOR TO NON DETACHMENT THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727330 ↗