Axium Prime Detachable Coil System APB-2-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00763000313692), received between Mar 27, 2022 and Apr 3, 2026 — classified as 3 deaths, 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED DURING COIL EMBOLIZATION. ANOTHER COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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, UNRUPTURED ANEURYSM LOCATED IN THE C6 SEGMENT WITH A MAX DIAMETER OF 6.5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781497 ↗
• MalfunctionJan 13, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL HAD A LOT OF RESISTANCE WHEN PUSHED THROUGH THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN DIDN'T DARE PUSH IT HARD, SO REPLACED IT WITH ANOTHER ONE. 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 INSTRUCTIONS FOR USE (IFU). NO PATIENT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054332 ↗
• MalfunctionDec 23, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE, BECAME STUCK AND COULD NOT BE ADVANCED THROUGH THE ECHELON 10 MICROCATHETER HUB. THE IMPLANT COIL BROKE WHEN THE PUSHWIRE WAS PULLED OUT. THE COIL WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH A MAX DIAMETER OF 2 MM AND A 1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882461 ↗
• MalfunctionDec 9, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DETACHMENT OF THE COIL COULD NOT BE ACHIEVED IN VIVO. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY VESSEL ANEURYSM WITH A MAX DIAMETER OF 3.8 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION, THE OPERATOR SELECTED A 2-4-3D COIL. AFTER HYDRATION, THE COIL WAS DELIVERED AND THE FILLING EFFECT WAS SATISFACTORY. HOWEVER, DETACHMENT COULD NOT BE ACHIEVED MANUALLY AT THE SECONDARY DETACHMENT POINT. MULTIPLE ATTEMPTS WERE MADE, AND SWITCHING TO ANOTHER DETACHMENT POINT ALSO FAILED TO ACHIEVE DETACHMENT. THE OPERATOR THEN CAREFULLY RETRIEVED THE COIL INTO THE MICROCATHETER AND PROCEEDED WITH THE PROCEDURE USING ANOTHER COIL OF A DIFFERENT LOT AND MODEL NUMBER. POSTOPERATIVELY, WHILE THE OPERATOR WAS EXAMINING THE COIL ON THE OPERATING TABLE, DETACHMENT OCCURRED. THE OPERATOR SUBSEQUENTLY REPORTED THE COMPLAINT. SUBSEQUENT COIL FILLING WITH THE ECHELON PROCEEDED SMOOTHLY, RULING OUT ANY ISSUES RELATED TO THE ECHELON. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763860 ↗
• InjuryNov 6, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT A COIL WAS BROKEN PRIOR TO DETACHMENT ATTEMPTS. NO OTHER DEVICE, EVENT, OR PATIENT INFORMATION WAS KNOWN AT THE TIME THE REPORT WAS RECEIVED.

  Patient problems: Foreign Body In Patient; Insufficient Information; Ischemia Stroke; No Clinical Signs, Symptoms or Conditions; Paresis

  MAUDE report 23488283 ↗
• MalfunctionNov 6, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON USED A COIL TO EMBOLIZE THE ANEURYSM. DURING THE FIRST ATTEMPT, THE COIL BASKET FORMATION WAS UNSATISFACTORY, SO THE COIL WAS RETRIEVED AND TRIED AGAIN. AFTER ABOUT FIVE ATTEMPTS, IT WAS FOUND THAT THE TIP OF THE COIL DID NOT MOVE DURING RETRIEVAL. COIL STRETCHED WAS SUSPECTED, SO THE MICROCATHETER AND COIL WERE WITHDRAWN TOGETHER. UPON INSPECTION, THE COIL WAS INDEED STRETCHED. AFTER REPLACING THE COIL, 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY CAVERNOUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.6MM 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 23487443 ↗
• MalfunctionAug 26, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 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 DETACHABLE COIL APB-2-4-3D-ES WAS SELECTED FOR FILLING. THE TAIL END OF THE COIL WAS STRETCHED AND REPLACED WITH ANOTHER COIL TO SUCCESSFULLY COMPLETE THE OPERATION. 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 THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WAS NO RESISTANCE. THERE WAS NO DAMAGE TO THE CATHETER WAS A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900469 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS FOUND TO BE DETACHED OUT OF PACKAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT BEFORE THE OPERATION, WHEN THE COIL PACKAGE WAS OPENED, IT WAS FOUND THAT THE COIL HAD BEEN DETACHED. CONSIDERING THE SAFETY OF THE OPERATION, A NEW AXIUM COIL WAS REPLACED AND IMPLANTED. THERE WAS NO ABNORMALITY IN THE ANGIOGRAPHY, AND THE OPERATION WAS CARRIED OUT SMOOTHLY. NO PATIENT INVOLVEMENT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731197 ↗
• MalfunctionJul 21, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH UNKNOWN DIAMETER.  IT WAS REPORTED THAT AFTER THE ECHELON MICROCATHETER WAS SHAPED, IT WAS FOUND THAT THE DISTAL END WAS DAMAGED. AFTER REPLACEMENT, IT WAS USED SMOOTHLY. IT  WAS ALSO REPORTED THAT THE AXIUM SPRING COIL WAS DIFFICULT TO DETACH AND MULTIPLE ATTEMPTS TO DETACH IT MANUALLY FAILED. AFTER REPLACEMENT, IT WAS SUCCESSFULLY IMPLANTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556057 ↗
• MalfunctionJul 18, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COILS STUCK/RESISTANCE OCCURRED IN THE MIDDLE OF THE ECHELON CATHETER. THE CATHETER WAS DAMAGED AT UNKNOWN LOCATION, AND THE COILS WAS DAMAGED AT PUSHWIRE MIDDLE SEGMENT. THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 1.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 8MM DIAMETER. IT WAS REPORTED THAT AFTER POSITIONING THE INTERMEDIATE CATHETER, THE ECHLENON10 MICROCATHETER (BATCH: 0229906497) WAS ADVANCED TO THE LESION SITE. THE FIRST COIL, APB-2-4-3D-ES (BATCH: 229115231), WAS SELECTED, AND THE SURGEON REPORTED SLIGHT RESISTANCE DURING DELIVERY BUT SUCCESSFULLY DEPLOYED AND DETACHED THE COIL. FLUID INFUSION WAS CHECKED AND FOUND TO BE FUNCTIONING NORMALLY. THE SECOND COIL, APB-1.5-3-3D-ES (BATCH: 229655742), ENCOUNTERED SIGNIFICANT RESISTANCE NEAR THE PROXIMAL END OF THE MICROCATHETER DURING DELIVERY. THE COIL'S PUSHER WIRE BECAME BENT, LEADING THE SURGEON TO SUSPECT A COIL QUALITY ISSUE. SINCE THE SAME MODEL WAS UNAVAILABLE, APB-1-1-HX-ES WAS SELECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545703 ↗
• MalfunctionJun 19, 2025Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE AXIUM PRIME BARE 3D 2MM X 4CM EXTRA SOFT COIL, THE DETACHMENT POINT OF THE COIL WAS FOUND TO BE DAMAGED WHEN THE COIL WAS OPENED. COIL SEPARATION, BREAK, OR PREMATURE DETACHMENT OCCURRED, AND THE PUSHWIRE WAS BENT OR BROKEN. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO FRICTION OR DIFFICULTY WAS ENCOUNTERED DURING DELIVERY, AND THE PHYSICIAN DID NOT ATTEMPT TO REPOSITION OR DETACH THE COIL, NOR WAS A MANUAL DETACHMENT ATTEMPT MADE. THE PUSHWIRE AND INSTANT DETACHER WERE PLANNED TO BE RETURNED FOR EVALUATION. THE PRODUCT WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293626 ↗
• MalfunctionJun 6, 2025Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THERE IS GOOD PATIENT RECOVERY AFTER THE SURGERY. SYMPTOMS INCLUDED BLOOD FLOW SLOWED. SLOW BLOOD FLOW, IMPROVED AFTER PUMPING XINWEINING, BUT SLOW BLOOD FLOW STILL EXISTED. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THERE WERE NO DETACHMENT ATTEMPTS MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS IMPLANTED AND LEFT IN THE PATIENT'S BLOOD VESSELS. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. AN ADDITIONAL STENT WAS USED TO COMPRESS THE DETACHED COIL AGAINST THE VESSEL WALL. ANCILLARY DEVICES INCLUDE A SAB-4-15, LOT NUMBER: B761834, AND AN ECHELON, LOT NUMBER 0229463303.

  Patient problems: Failure of Implant; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 22161642 ↗
• MalfunctionJun 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT 2 AXIUM COILS WERE STUCK IN THE CATHETER. THE DOCTOR PREPARED AND CANNULATED THE ARTERY TO TREAT AN ANEURYSM IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), FOR WHICH WHEN PASSING THE QC-2-6-3D COIL IT DOES NOT ADVANCE THROUGH THE HYPOTUBE FOR PASSAGE THROUGH THE MICROCATHETER. IT WAS REPORTED THE COIL WAS STUCK IN THE CATHETER HUB AND IT WAS ALSO STUCK IN THE DISTAL SECTION OF THE CATHETER. THE CATHETER AND COILS WERE NOT DAMAGED. THE APB-2-4-3D-ES COIL WAS STUCK IN AN ECHELON CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, FUSIFORM ANEURYSM IN THE PICA. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE WAS IN THE HUB. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131011 ↗
• MalfunctionMar 5, 2025Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED LEFT C6 ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 6 MM AND NECK DIAMETER 5 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. WHEN USED THE EMBOLIZATION MICROCATHETER FOR DELIVERING THE COIL, IT WAS STRETCHED BEFORE REACHING THE TUMOR SAC. THE COIL WAS REMOVED FROM THE PATIENT. 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 REPOSITION THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526614 ↗
• 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 21434375 ↗
• MalfunctionFeb 13, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A COIL ENCOUNTERED RESISTANCE/WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT WHILE TAKING THE FIRST COIL APB-2-4-3D, THE COIL GOT STUCK AT THE SHEATH ITSELF SHOWING A LOT OF RESISTANCE AND NOT PASSING INTO THE CATHETER. IT WAS NOTED THAT THE COIL GOT DAMAGED. 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 WAS RECEIVED THAT THERE WAS SO MUCH RESISTANCE IN THE SHEATH ITSELF THAT COIL WAS NOT ABLE TO PASS. WHILE TAKING IT BACK TO THE SHEATH, THE COIL GOT STUCK IN THE MICROCATHETER AS WELL, HENCE THE COIL GOT BOTH RESISTANCE AND DAMAGED. THE CAUSE OF THE RESISTANCE AND DAMAGE WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375171 ↗
• MalfunctionJan 13, 2025Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT STRETCHED DURING DELIVERY AND SEPARATED/BROKE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT MIDDLE CEREBRAL ARTERY (MCA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AND CONTINUOUS CATHETER FLUSH WAS ADMINISTERED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS SOME FRICTION/DIFFICULTY DURING DELIVERY. DURING THE FILLING PROCESS, WHEN ONLY ABOUT 1CM OF THE COIL REMAINED TO BE DELIVERED, THERE WAS A SUDDEN STRETCHING OF THE COIL; THE COIL BROKE THOUGH IT WAS NOTED THE COIL WAS NOT DETACHED. IT WAS NOTED THAT THE COIL WAS REPOSITIONED TWICE BUT THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER OR TRY TO DETACH THE COIL DURING THE PROCEDURE. THE COIL WAS REMOVED FROM THE PATIENT'S BODY USING SOLITAIRE AB (SAB); NO OTHER SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR OTHER COMPLICATI

  Patient problems: Foreign Body In Patient

  MAUDE report 21138652 ↗
• MalfunctionNov 18, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. NO INSTANT DETACHER WAS USED. 2 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708299 ↗
• MalfunctionOct 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE AND WAS STUCK IN THE DISTAL SECTION OF THE CATHETER.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT VERTEBRAL ARTERY V4 WITH A MAX DIAMETER OF 3.6MM AND A 1.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT IN THE RIGHT VERTEBRAL V4 ANEURYSM, AFTER AN ECHELON10 WAS BROUGHT TO THE LESION VIA AVIGO, APB-2-4-3D WAS USED FOR EMBOLIZATION. IT WAS SOON DISCOVERED THAT THE SPRING COIL COULD NOT BE PUSHED OUT. EVEN AFTER PUSHING THE MIDDLE CATHETER TO GO UPPER, THE SPRING COIL COULD NOT BE PUSHED OUT. IT WAS THEN REPLACED WITH A NEW APB-2-4-3D-ES AND DEPLOYED SUCCESSFULLY. THE CATHETER AND COIL WERE NOT DAMAGED. 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 WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487295 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROFESSOR USED A STENT TO APPOSITION THE COIL TO THE WALL. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354825 ↗
• MalfunctionSep 26, 2024Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DAMAGE WAS ALREADY FOUND WHEN REMOVED FROM THE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. DISTAL PART OF THE COIL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317028 ↗
• MalfunctionSep 19, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS RETURNED INWARD DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258591 ↗
• MalfunctionJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 3.1MM AND A 2.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL TIP WAS FOUND TO BE DETACHED DURING IMPLANTATION AND COULD NOT BE IMPLANTED NORMALLY. THE COIL WAS REMOVED FROM THE PATIENT BY WITHDRAWING THE MICROCATHETER AND PUSHING THE COIL OUT OF THE MICROCATHETER. 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 REPOSITION THE COIL OR 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 INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748858 ↗
• MalfunctionJun 17, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. IT WAS UNKNOWN IF THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNKNOWN CONDITION. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WAS UNKNOWN. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. FIVE ATTEMPTS WERE MADE WITH A 2ND INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THREE ATTEMPTS WERE MADE WITH THE MANUAL METHOD. NO ISSUE WITH THE INSTANT DETACHER WAS NOTED. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548438 ↗
• MalfunctionJun 11, 2024Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED AFTER NON-DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 3MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL WAS DELIVERED INTO THE ANEURYSM TO FORM A HOOP. AFTER DETACHING WITH THE DETACHER, WHEN PREPARING TO WITHDRAW, IT WAS FOUND THAT THE SPRING COIL WAS NOT DETACHED. THEN, AFTER SEVERAL MANUAL DETACHMENT ATTEMPTS, IT STILL FAILED, SO IT WAS TRIED TO SLOWLY WITHDRAW THE SPRING COIL. DURING THE WITHDRAWAL PROCESS, IT WAS FOUND THAT THE SPRING COIL HAD DETACHED ITSELF IN THE MICROCATHETER, SO THE SPRING COIL AND THE MICROCATHETER WERE WITHDRAWN AS A WHOLE, REPLACED THE COIL, AND RE-EMBOLIZED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH WITH THE INSTANT DETACHER AND MANUAL METHOD 2 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510293 ↗