AxiumTM APB-3.5-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00847536021259), received between Nov 1, 2018 and Nov 25, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (11 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.

• MalfunctionNov 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER ACCESS WAS ESTABLISHED, A 4-8 COIL WAS FILLED IN THE ANEURYSM USING AN ECHELON MICROCATHETER. A SECOND COIL, AXIUM PRIME BARE 3D, WAS DELIVERED HALFWAY INTO THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. IT WAS NOTED THAT THE COIL WAS STUCK AT THE CATHETER HUB. THE COIL WAS REPLACED WITH A NEW COIL OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR, 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. 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 AND THERE WAS NO CATHETER OR COIL DAMAGE. ADDITIONAL INFORMATION WAS RECEIVED. COIL RESISTANCE WAS ENCOUNTERED IN THE MIDDLE OF THE CATHETER. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED; HOWEVER, THE CUSTOMER TENDED TO BELIEVE THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649543 ↗
• MalfunctionMay 13, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2025, HEALTHCARE PROVIDER (HCP) PERFORMED EMBOLIZATION OF THE LEFT ANTERIOR CEREBRAL COMMUNICATING ARTERY ANEURYSM. AFTER THE MIDDLE CATHETER WAS IN PLACE, A 45° ECHELON10 MICROCATHETER (UNMOLDED) WAS SELECTED. AFTER THE MICROCATHETER WAS IN PLACE WITH A GUIDE WIRE, THE FIRST SPRING COIL WAS SELECTED AS APB-3.5-6-3D-ES. WHEN DELIVERING THE SPRING COIL, THE SPRING COIL FELT A LITTLE BIT OF RESISTANCE WHEN IT WAS PUSHED IN THE MICROCATHETER. WHEN IT REACHED THE MIDDLE OF THE MICROCATHETER, THE SPRING COIL COULD NOT BE PUSHED. THE PUSH ROD OF SPRING COIL WAS KINKED IN MANY PLACES. AFTER REPEATED ATTEMPTS, THE SURGEON STILL FAILED. HE THOUGHT THAT THERE WAS A QUALITY PROBLEM WITH THE MICROCATHETER, SO WITHDREW THE COIL AND MICROCATHETER AND REPLACED THE MICROCATHETER SL10 FROM ANOTHER MANUFACTURER TO REACH THE LESION SITE. BECAUSE THE APB-3.5-6-3D-ES PUSH ROD WAS KINKED, THE SURGEON WAS WORRIED THAT THERE WOULD BE PROBLEMS WITH THE DELIVERY AGAIN, SO HE REPLACED THE STRYKER COIL FOR DELIVERY. THE LESION SITE WAS SUCCESSFULLY REACHED TO FILL THE ANEURYSM. THREE COILS WERE FILLED SUCCESSIVELY. THE ANGIOGRAPHIC ANEURYSM WAS DENSELY FILLED AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014982 ↗
• MalfunctionApr 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE ANEURYSM BEING TREATED WAS IN THE LEFT MIDDLE CEREBRAL ARTERY. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867251 ↗
• MalfunctionNov 7, 2024Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED THAT THE COIL DID NOT DETACH PREMATURELY, THE SPRING COIL WAS DETACHED MULTIPLE TIMES THROUGH THE TA IL END IN THE TUMOR, BUT IT WAS NOT DETACHED SUCCESSFULLY. THE COIL DID NOT BREAK OR SEPARATE AT ANY POSITION OTHER THAN THE DETACHMENT POINT. THE FIRST TIME WAS FAILED TO DETACH AND ALSO CONFIRMED THE DETACHMENT POINT AND SITUATION OF FORMING A HOOP SEVERAL TIMES. TRIED MANUAL DETACHMENT; TRIED MULTIPLE DETACHMENTS, AT LEAST FIVE TIMES. THIS COIL WAS IMPLANTED FOR THE FIRST TIME, AND AFTER UN SUCCESSFUL DETACHMENT, PERFORMED DENSE MESH IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630765 ↗
• MalfunctionNov 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS PRE-DETACHED IN THE MICROCATHETER SO THE WHOLE PROCEDURE SYSTEM WAS TAKEN OUT FROM THE PATIENT AND THE AXIUM COIL WAS REMOVED. THE PUSHWIRE WAS NOT BENT/BROKEN. THERE WAS NO FRICTION/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 AXIUM COIL AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18179242 ↗
• MalfunctionJun 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. THAT THE PATIENT, DID NOT EXPERIENCE ANY ADVERSE EVENT OR INJURY IN ASSOCIATION WITH THIS EVENT. LESION CHARACTERISTICS INCLUDE ANTERIOR COMMUNICATING ARTERY 4 MM ANEURYSM. VESSEL TORTUOSITY WAS NORMAL. THE PROCEDURE WAS COMPLETED, AS THE COIL HAD BEEN CUT. THE PROCEDURE WAS COMPLETED WITH ADDED NEW COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238861 ↗
• MalfunctionDec 14, 2022Display or Visual Feedback Problem; Stretched; Physical Resistance/Sticking; Display or Visual Feedback Problem; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY AND POOR VISUALIZATION DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY PARACLINOID SEGMENT SPI NDLE-SHAPED ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS THE SECOND TO BE USED IN THE PROCEDURE. THERE WAS STRONG RESISTANCE DURING DELIVERY OF THE COIL AND DURING INSERTION INTO THE ANEURYSM. THE COIL WAS ALMOST FULLY DELIVERED OUT OF THE MICROCATHETER WHEN IT WAS OBSERVED THAT THE THE DELIVERY WIRE DETACHMENT MARKER WAS NOT VISIBLE IN PROCEDURAL IMAGING. BECAUSE OF THE LACK OF VISIBILITY, IT WAS SUSPECTED BY THE SURGEON THAT THERE MAY HAVE BEEN BREAKAGE ON THE PROXIMAL END OF THE COIL SO THE COIL WAS RETRIEVED AND IT WAS OBSERVED THAT THE COIL WAS STRETCHED/EXTENDED. NO ATTEMPT WAS MADE TO REPOSITION THE COIL. IT WAS NOTED THAT CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS REPLACED WITH ANOTHER MANU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977754 ↗
• MalfunctionNov 18, 2022Therapy Delivered to Incorrect Body Area; Separation Failure; Detachment of Device or Device Component; Therapy Delivered to Incorrect Body Area; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE POOR COIL DETACHMENT WAS NOT DETERMINED. THE SEPARATION SYSTEM WAS IN OPERATION SO THE SALES REP PREDICTED THAT THE BALL JOINT AND THE TIP MIGHT HAVE BEEN CAUGHT. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS IMPLANTED IN THE ORIGINAL INTENDED LOCATION BUT WAS FORCED TO EMBOLIZE SO IT DISLODGED TO THE MOTHER VESSEL. NO ADDITIONAL TREATMENT IS SCHEDULED AT THIS POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825637 ↗
• MalfunctionNov 4, 2022Separation Failure; Separation Failure

  NEW INFORMATION RECEIVED. THERE WERE NO ISSUES, PRIOR TO COIL NON-DETACHMENT. IT IS UNKNOWN, IF THERE WAS ANY PUSHWIRE DAMAGE OBSERVED, AFTER REMOVAL FROM THE PATIENT. THE CAUSE OF THE COIL NON-DETACHMENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738397 ↗
• MalfunctionMay 23, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED BY USING DETACHER DESPITE SEVERAL ATTEMPTS. THE PHYSICIAN ATTEMPTED TO THE DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ICA WITH A MAX DIAMETER OF 3.5MM AND A 1.7MM 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 14471034 ↗
• MalfunctionMay 13, 2022Break; Separation Failure; Physical Resistance/Sticking; Break; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED AND EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED USING THE INSTANT DETACHER (ID). TWO ATTEMPTS WERE MADE WITH THE ID. MANUAL DETACHMENT WAS ALSO ATTEMPTED ONCE, BUT IT WAS NOT SUCCESSFUL. IT WAS REPORTED THAT THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT, AND THE COIL WAS COLLECTED BY PULLING ON THE DELIVERY WIRE. THE COIL HAD NOT BEEN REPOSITIONED, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THERE WAS ALSO RESISTANCE IN THE PROXIMAL SHAFT OF THE PHENOM 17 MICROCATHETER. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED, AND THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398153 ↗
• MalfunctionApr 12, 2022Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL EXPERIENCED RESISTANCE IN THE ECHELON 10 MICROCATHETER, WAS STRETCHED, AND BROKE/SEPARATED/PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT AFTER THE COIL WAS STUCK IN THE CATHETER, THEY TOOK THE PUSH ROD AND COIL OUT OF THE BODY AND FOUND THAT THE COIL BODY WAS STRETCHED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE DELIVERY PUSHER WAS NOT ROTATED DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087173 ↗
• MalfunctionApr 7, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM PRIME COILS INITIALLY FAILED TO DETACH. THE FIRST COIL UNINTENTIONALLY DETACHED DURING REMOVAL, AND THE SECOND WAS LATER ABLE TO BE SUCCESSFULLY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT IC-ANCHRO REGION. THE MAX DIAMETER WAS 3.5MM, AND THE NECK DIAMETER WAS 1.6MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT FIRST REPORTED COIL WAS ATTEMPTED TO BE DETACHED TWICE WITH THE INSTANT DETACHER. WHEN SWITCHED TO A SEPARATE DETACHER, DETACHMENT WAS STILL NOT POSSIBLE. ONE MANUAL DETACHMENT WAS MADE, AND THE COIL STILL COULD NOT BE DETACHED. AN ATTEMPT WAS MADE TO COLLECT THE COIL, BUT WHEN IT RETURNED A LITTLE LESS THAN 2CM INSIDE THE CATHETER, THE COIL WAS DETACHED. THE COIL WAS PUSHED USING A GUIDEWIRE AND WAS PLACED IN THE ANEURYSM. THE SECOND REPORTED COIL WAS ATTEMPTED TO BE DETACHED THREE TIMES WITH THE INSTANT DETACHER, BUT COULD NOT BE DETACHED. THE PATIENT HAD TWO ANEURYSMS, SO THE COIL WAS PLACED IN THE SECOND ANEURYSM AND WAS ABLE TO BE SUCCESSFULLY DETACHED WITH THE INSTANT DETACHER. THE PROCEDURE WAS COMPLETED. THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048078 ↗
• MalfunctionDec 12, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INSTANT DETACHER LOT NUMBER IS B238132. THERE WERE NO ISSUES IN PARTICULAR THAT LED TO THE ENCOUNTERED ISSUES. THERE WERE NO ISSUES NOTED WITH THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981890 ↗
• MalfunctionSep 29, 2021Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE ARTERIOVENOUS MALFORMATION (AVM) LIQUID EMBOLIZATION, THE MOTHER BLOOD VESSEL WAS DAMAGED RESULTING IN HEMORRHAGE. AN ATTEMPT WAS TO BE MADE TO INDUCE THE DEVICE FROM THE SL-10 AS A COIL FOR HEMOSTASIS, BUT THE PHYSICIAN CONFIRMED THAT THE DELIVERY PUSHER WAS BROKEN WHEN THE PACKAGE WAS REMOVED FROM THE BOX AND OPENED. UPON CHECKING THE PRODUCT, THE PROXIMAL SEGMENT WAS BROKEN AND THE RELEASE WIRE WAS PEELED OFF, SO IT WAS JUDGED DANGEROUS TO USE. A REPLACEMENT COIL OF THE SAME SIZE WAS SUBSTITUTED, AND THE TREATMENT WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR HEMOSTASIS OF INTRACEREBRAL HEMORRHAGE THAT OCCURRED DURING TREATMENT OF AVM LIQUID EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A 7F SHEATH, 7F LOAD MASTER, SL10, SCEPTERC, TRAXCESS14. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. THE LIQUI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550560 ↗
• MalfunctionSep 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS PREMATURELY DETACHED BEFORE DEPLOYMENT. THE COILS WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PATIENT'S BLOOD FLOW WAS NORMAL. ANCILLARY DEVICES INCLUDE A BOSTON SCIENTIFIC XF GUIDER SOFT TIP GUIDE CATHETER, EXCELSIOR SL-10 MICROCATHETER, AND TRANSEND EX-SOFT GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541123 ↗
• MalfunctionFeb 15, 2021Difficult or Delayed Positioning; Separation Failure; Difficult or Delayed Positioning; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330436 ↗
• MalfunctionJan 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL ENCOUNTERED RESISTANCE/STUCK IN THE CATHETER DURING THE COILING TREATMENT. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS NOT DAMAGED. THE COILS WERE NOT DAMAGED. NO CONTINUOUS FLUSH WAS NOT USED IN THE PROCEDURE. THE VESSEL WAS NORMAL TORTUOUS. NO PATIENT INJURY WAS REPORTED. EVEN WITH THE DEVICE DEFECT THERE WAS NO COMPLICATION IN THE PROCEDURE, NORMAL BLOOD FLOW AND NO CHANGE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. NO PATIENT INJURY REPORTED. NO IMAGES AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581353 ↗
• MalfunctionMay 31, 2019Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME COIL WAS EMBOLIZED INTO THE RIGHT SIDE ACOM ANEURYSM. HOWEVER, THE COIL FAILED TO DETACH. THE DETACHMENT WAS ATTEMPTED 3 TIMES AND THE DEVICE WAS RETRIEVED. THE COIL WAS REPORTED TO HAVE SUCCESSFUL BEEN RETRIEVED BUT STRETCHED IN THE HUB AS RESISTANCE WAS ENCOUNTERED. 3 COILS WERE SUCCESSFULLY IMPLANTED WITH THE SAME INSTANT DETACHER. THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. A NEW DETACHER WAS NOT USED, AND MANUAL DETACHMENT WAS NOT ATTEMPTED. NO PATIENT INJURY WAS REPORTED. THE DEVICE AND THE ANCILLARY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS PER THE IFU. THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT ACOM ANEURYSM THAT WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 3.6MM WITH A NECK WIDTH OF 1.4MM. THE BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658607 ↗
• MalfunctionApr 10, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT OF AXIUM PRIME COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING STENT ASSISTED COILING OF AN UNRUPTURED CEREBRAL ANEURYSM LOCATED IN BA-TOP. THE ANATOMY WAS REPORTED TO HAVE BEEN MODERATE IN TORTUOSITY. THE VESSEL DIAMETER WAS MEDIUM. THE ANEURYSM WAS 4MM. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE ATLAS STENT WAS PLACED FROM THE LEFT PCA. ECHELON10 (105-5091-150) WAS USED IN JAILING TECHNIQUE AND PRIME3.5-6 WAS IMPLANTED AS THE 1ST COIL. THE PHYSICIAN TRIED TO DETACH THE AXIUM PRIME COIL, BUT IT WAS UNABLE TO BE DETACHED. ID-1 WAS REPLACED WITH ANOTHER LOT, BUT STILL THE DETACHMENT WAS UNABLE TO BE PERFORMED. THE PHYSICIAN TRIED MANUAL DETACHMENT, BUT STILL IT WAS UNABLE TO BE DETACHED. WHEN TRYING TO REMOVE, ALL THE COIL ENTERED THE MICROCATHETER AND THE COIL WAS DETACHED. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8502305 ↗
• MalfunctionJan 22, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING A COILING TREATMENT OF CEREBRAL ANEURYSM, UPON OPENING THE PRODUCT AND CHECKING THE PUSHWIRE, THE BREAK INDICATOR PART WAS NOTED TO BE KINKED. A NEW DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THE EVENT OCCURRED PRIOR TO USE FOR PATIENT. NO DAMAGE TO OUTER /INNER PACKAGE OF THE DEVICE WAS REPORTED. THERE WAS NO EVIDENCE OF TAMPERING TO THE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8267465 ↗
• MalfunctionNov 1, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER BUT IT FAILED, SO THEY TRIED TO RELEASE IT BY BREAKING THE BREAK INDICATOR BUT IT STILL WOULD NOT DETACH. THE DOCTOR THEN SLIGHTLY PUSHED AND PULLED THE DELIVERY PUSHER SEVERAL TIMES WHICH ALLOWED THE COIL TO DETACH AND THE PROCEDURE TO COMPLETE WITHOUT ISSUE. THIS WAS LATER DESCRIBED AS THE PART FALLING INTO THE PATIENT'S CAVITY AND BEING UNABLE TO BE RETRIEVED. PRIOR TO THIS TWO OTHER COILS HAD BEEN PLACED SUCCESSFULLY. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY TO TREAT A 9MM X 5MM ANEURYSM. THERE WERE NO RELATED PATIENT SYMPTOMS. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE WITH NO ABNORMALITIES. ANCILLARY DEVICES INCLUDE AN SL-10 CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028080 ↗