Axium Prime Detachable Coil System APB-2-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000313890), received between Sep 27, 2021 and Aug 17, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286712 ↗
• MalfunctionFeb 26, 2026Difficult or Delayed Positioning; Stretched; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED.THE MAXIMUM DIAMETER OF THE ANEURYSM WAS REPORTED TO BE 6 MM, WITH A NECK DIAMETER OF 4 MM. THE HCP CLARIFIED THAT ONLY THE APB-1-1-HX-ES COIL WAS ABANDONED AND DISCARDED. THE STRETCHED COIL, APB-2-6-HX-ES, WAS NOT REMOVED AND REMAINED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462300 ↗
• MalfunctionFeb 13, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED, IT WAS ONLY REPORTED, "THE COIL COULD NOT BE DETACHED AFTER DELIVERY." THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER THE REMOVAL FROM THE PATIENT. THE ANEURYSM LOCATION WAS REPORTED AS RIGHT VERTEBRAL ARTERY V4 SEGMENT. A SUMMARY OF THE EVENT WAS PROVIDED AS, "THE PATIENT'S ANGIOGRAPHY REVEALED A RIGHT VERTEBRAL ARTERY V4 SEGMENT ANEURYSM. AN ANEURYSM EMBOLIZATION PROCEDURE WAS PLANNED. A FEMORAL ARTERY PUNCTURE WAS PERFORMED TO ESTABLISH A ACCESS. AFTER THE MICROCATHETER WAS IN PLACE, COIL WAS DELIVERED FOR INTRA-ANEURYSM EMBOLIZATION. WHEN DELIVERING THE APB-2-6-HS-ES COIL, THE OPERATOR FOUND THAT THE COIL COULD NOT BE DETACHED. AFTER SEVERAL ATTEMPTS, IT STILL COULD NOT BE DETACHED. THE COIL WAS THEN REMOVED AND REPLACED WITH A NEW ONE. THE OPERATION WAS COMPLETED SAFELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334683 ↗
• MalfunctionJan 9, 2026Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE/WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A POSTERIOR COMMUNICATING ARTERY (PCOM) RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. PATIENT'S BLOOD FLOW WAS NORMAL; VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). WHEN THE INTRODUCER SHEATH WAS PRESSED AGAINST THE Y-VALVE, THERE WAS SIGNIFICANT RESISTANCE WHEN ADVANCEMENT WAS ATTEMPTED. THE COIL HAD RESISTANCE/WAS STUCK IN THE SHEATH. WHEN THE COIL WAS WITHDRAWN, IT WAS FOUND DAMAGED/STRETCHED. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: LONG SHEATH, SINO INTERMEDIATE GUIDE CATHETER, ECHELON MICROCATHETER ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE COIL RESISTANCE AND THE COIL BECOMING STUCK IN THE SHEATH WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020029 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, COIL PREMATURE DETACHMENT OCCURRED INTO THE MICROCATHETER'S DISTAL PORTION BEFORE COMPLETING THE WALL APPOSITION IN ACOM ANEURYSM. THE PHYSICIAN THEN CAREFULLY REMOVED FULL SYSTEM, LIKE GUIDE CATHETER, MICRO CATHETER WITH DAMAGE COIL FROM THE PATIENT'S RIGHT ACOM SEGMENT WITHOUT MOVING FORWARD. THE PATIENT WAS ALIVE WITH NO INJURY DURING THE PROCEDURE. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. A 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A MAX DIAMETER OF 5.6MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. ANCILLARY DEVICES INCLUDE A TERUMO RADIO FOCUS 7 F SHEATH, ENVOY 6 F GUIDE CATHETER, ECHELON 10, LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176151 ↗
• MalfunctionMay 8, 2025Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE EMBOLIZATION OF AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT OPHTHALMIC ARTERY, THERE WERE SUSPECTED COIL STRETCHES DURING THE DELIVERY OF THE AXIUM PRIME BARE HX 2MM X 6CM EXTRA (APB-2-6-HX-ES) AND AXIUM PRIME BARE 3D 3MM X 6CM EXTRA SOFT (APB-3-6-3D-ES). THE APB-2-6-HX-ES EXPERIENCED FRICTION OR DIFFICULTY DURING DELIVERY, AND THE COIL STRETCH/DAMAGE WAS NOTED AT THE PUSHWIRE MIDDLE SEGMENT. THE APB-3-6-3D-ES HAD A COIL STRETCH AT THE PUSHWIRE DISTAL SEGMENT. THE DELIVERY OF OTHER SPRING COILS WAS NORMAL AND THE OPERATION WAS SUCCESSFUL. THE ANEURYSM DIMENSIONS MEASURED A MAX DIAMETER OF 3.66 MM AND A NECK DIAMETER OF 2.15 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE SURGEON REMOVED THE COILS AND CONTINUED THE OPERATION. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE STRETCH/ PUSHWIRE DAMAGE/ RESISTANCE WAS NOT DETERMINED. WHEN THE SPRING COIL WAS DELIVERED TO THE MIDDLE SECTION, RESISTANCE WAS GENERATED. THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985553 ↗
• MalfunctionDec 4, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STUCK IN THE CATHETER/SHEATH AND 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 SMALL ANEURYSM OF THE RIGHT POSTERIOR COMMUNICATING ARTERY WITH AN AMORPHOUS MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4.5 MM AND NECK DIAMETER 3.2 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. WHEN THE COIL WAS PUSHED INTO THE MICROCATHETER AFTER HYDRATION, GREAT RESISTANCE WAS FOUND. WHEN IT WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE SPRING COIL HAD BEEN STRETCHED. THE RESISTANCE WAS FOUND IN THE PROXIMAL END OF THE CATHETER. THE COIL PUSHED SMOOTHLY OUT FROM THE SHEATH. THE CATHETER WAS NOT DAMAGED. IT WAS UNKNOWN IF THE COIL WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. THE CAUSE OF THE COIL RESISTANCE/STRETCH WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846462 ↗
• MalfunctionNov 14, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL FAILED TO DETACH. THE PATIENT WAS SENT TO THE CATHETERIZATION ROOM FOR SURGERY ON (B)(6) 2024 DUE TO SUBARACHNOID HEMORRHAGE. THE DSA ANGIOGRAPHY RESULTS SHOWED INTRACRANIAL ANEURYSM, AND THE SURGEON DECIDED TO PERFORM INTRACRANIAL ANEURYSM EMBOLIZATION. AFTER THE COIL WAS PLACED IN THE PREDETERMINED POSITION OF THE ANEURYSM, A CONVEYOR WAS USED FOR MECHANICAL DETACHMENT, BUT THE SURGEON FAILED TO DETACH IT AFTER MULTIPLE ATTEMPTS. THE SURGEON COULD ONLY GRADUALLY RETRIEVE AND WITHDRAW THE COIL AND REPLACED IT WITH ANOTHER COIL FOR USE. THE SUBSEQUENT OPERATION WENT SMOOTHLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20680159 ↗
• MalfunctionSep 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED NORMALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.72 MM AND A 2.81 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL COULD NOT BE PUSHED NORMALLY DURING THE SURGERY, AND THE ES COIL WAS REPLACED AFTER MULTIPLE ATTEMPTS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128453 ↗
• MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ATTEMPTS TO DETACH THE CATHETER. THE CAUSE OF THE DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125489 ↗
• MalfunctionAug 15, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGERY STARTED AT 19:05 AND ENDED 00:05 FOR A TOTAL TIME OF 300 MINUTES. PREOPERATIVE DIAGNOSIS: 1. MULTIPLE INTRACRANIAL ANEURYSMS WITH SUBARACHNOID HEMORRHAGE (H-H GRADE 2)) 1.2. RECURRENCE OF RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM AFTER EMBOLIZATION; 1.3. ANTERIOR COMMUNICATING ARTERY ANEURYSM; 2. HYPERTENSION. POSTOPERATIVE DIAGNOSIS: 1. MULTIPLE INTRACRANIAL ANEURYSMS WITH SUBARACHNOID HEMORRHAGE (H-H GRADE 2) 1.2. RECURRENCE OF RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM AFTER EMBOLIZATION; 1.3. ANTERIOR COMMUNICATING ARTERY ANEURYSM; 1.4 MULTIPLE ANEURYSMS OF THE C3-C4 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY 1.5 ANEURYSM OF THE M2 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY; 2. HYPERTENSION 3. MULTIPLE CEREBRAL ARTERIOSCLEROSIS AND STENOSIS. OPERATION PROCESS: SUPINE POSITION, ROUTINE DISINFECTION AND DRAPING, RIGHT FEMORAL ARTERY PUNCTURE, INSERTION OF 5F ARTERIAL SHEATH, 5F ANGIOGRAPHY CATHETER, 0.035 ANGIOGRAPHY GUIDEWIRE, AND SELECTION OF RIGHT COMMON CAROTID ARTERY ANGIOGRAPHY. PLAQUE WITH MILD STENOSIS WAS FOUND AT THE BEGINNING OF THE RIGHT INTERNAL CAROTID ARTERY, AND TWO ANEURYSMS IN THE C3-C4 SEGMENT OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991523 ↗
• MalfunctionFeb 5, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ACTIONS/INTERVENTIONS THAT WERE TAKEN TO RESOLVE THE AXIUM COIL NON-DETACHMENT INCLUDED TRYING MULTIPLE TIMES TO PULL OUT, TAKE OFF SILK, AND GET RID OF IT. THE PROCEDURE WAS COMPLETED BY WITHDRAWING THE AXIUM COIL AND MICROCATHETER AND RE-OPERATED WITH MICROCATHETER. THE INSTANT DETACHER WAS NOT USED AND THE MANUAL METHOD WAS ATTEMPTED 2 TIMES. PRIOR TO THE COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE P ATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640476 ↗
• MalfunctionJan 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PUSH ROD COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS LOW AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE SPRING COIL EMBOLIZATION WAS COMPLETED, IT WAS SUCCESSFULLY DETACHED, BUT THE SPRING COIL PUSH ROD COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. IN THE END, THE MICROCATHETER AND THE PUSH ROD COULD ONLY BE WITHDRAWN FROM THE BODY TOGETHER; THE MICROCATHETER USED WAS MV COMPANY'S HEADWAY 17. THEY WERE SENT BACK TO THE COMPANY TOGETHER. THIS SURGERY WAS DOUBLE MICROCATHETER EMBOLIZATION, BUT THE SPRING COIL PUSH ROD COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVEN T. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PUSH ROD RESISTANCE WAS NOT DETERMINED. IT WAS NOTED THAT THE RESISTANCE SEEMED TO O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519342 ↗
• MalfunctionJan 16, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM SPRING COIL COULD NOT BE DETACHED AFTER MANY ATTEMPTS. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 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). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518889 ↗
• MalfunctionJan 8, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CASUE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED, DETACHMENT WAS FOUND DURING DELIVERY IN THE MICROCATHETER. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. NO DETACHMENTS ATTEMPTS WERE MADE. THE DAMAGE OCCURRED BEFORE THE DELIVERY WAS COMPLETED. THE COIL WAS REMOVED FROM THE PATIENT. THE COIL WAS NOT IMPLANTEDAT THE INTENDED LOCATION. THE CATHETER WAS AN ECHELON 10 CATHETER. TWO COILS WERE IMPLNATED BEFORE THE EVENT AND 2 COILS WERE IMPLANTED AFTER. NO SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465326 ↗
• MalfunctionJan 2, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT C6 WITH A MAX DIAMETER OF 3.2 MM AND A 2.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE SPRING COIL COULD NOT BE DETACHED DURING DELIVERY. AFTER SEVERAL ATTEMPTS, IT FAILED AND THE COIL WAS FORCIBLY WITHDRAWAL FROM THE BODY. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH ANOTHER INSTANT DETACHER. THERE WERE TWO MANUAL ATTEMPTS MADE 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 INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430886 ↗
• MalfunctionNov 1, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL GOT STUCK HALFWAY INTO THE MICROCATHETER. RETRIEVED BACK TO THE DELIVERY SHEATH AND PUSHED OUT THE SPRING COIL, IT WAS FOUND THAT A PART OF THE TIP WAS STRETCHED. SCISSORS WAS USED TO MINUS A SECTION, AND DELIVERED INTO THE MICROCATHETER, IT WAS STILL STRETCHED. THEN AN AXIUM COIL WAS REPLACED TO STUFF IN THE TUMOR, AND THE ANGIOGRAPHY SHOWED NO IMAGING OF THE TUMOR, AND THEN THE STENT WAS DEPLOYED. AFTER ANTEROPOSTERIOR AND LATERAL ANGIOGRAPHY, THE OPERATION ENDED. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED  LEFT MIDDLE CEREBRAL ARTERY M2 ANEURYSM WITH A MAX DIAMETER OF 4.1MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A 6F GUIDING + ECHELON + SL10 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE PROXIMAL END OF THE CATHETER. THE COIL CAME OUT OF THE INDUCER SHEATH SMOOTHLY. IT WAS NOTED THAT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050842 ↗
• MalfunctionOct 9, 2023Stretched; Separation Failure; Stretched; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. NO INSTANT DETACHER WAS USED. THERE WERE 2 ATTEMPTS MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THE COIL STRETCH WAS ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902208 ↗
• MalfunctionMar 16, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE OPERATOR DIRECTLY USED MANUAL DETACHMENT WITHOUT USING THE DETACHER. PRIOR TO COIL NON- DETACHMENT NO ISSUES WERE ENCOUNTERED. NO DAMAGE TO THE PUSHWIRE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13783496 ↗
• InjuryNov 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED AND REMAINED IN THE PATIENT AT AN UNINTENDED LOCATION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.42MM, AND THE NECK DIAMETER WAS 2.83MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE MICROCATHETER WAS USED FOR POST TREATMENT. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, AND NO DETACHMENT ATTEMPTS WERE MADE. THE PHYSICIAN DID ROTATE THE DELIVERY WIRE DURING THE PROCEDURE, AND A CONTINUOUS FLUSH WAS ADMINISTERED. THE PUSHWIRE WAS NOT BEND OR BROKEN. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR SYMPTOMS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

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

  MAUDE report 12756400 ↗
• MalfunctionSep 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532522 ↗