AxiumTM APB-2-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00847536021198), received between Nov 6, 2018 and Oct 22, 2025 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM IN THE LEFT OPHTHALMIC ARTERY SEGMENT. A MICROWIRE WITH A MICROCATHETER WAS ADVANCED INTO THE ANEURYSM SAC. AN APB-2.5-4-3D COIL WAS FIRST SELECTED TO FORM A BASKET. WHEN THE SECOND APB-2-4-3D SPRING COIL WAS PLACED, IT WAS FOUND THAT THE SPRING COIL COULD NOT BE PUSHED OUT. FOR THE SAFETY OF THE PROCEDURE, A NEW COIL OF THE SAME SPECIFICATION WAS USED INSTEAD. SUBSEQUENTLY, AN APB-1.5-4-3D COIL WAS PLACED, BUT IT ALSO FAILED TO PUSHED OUT. THE APB-1.5-4 COIL WAS WITHDRAWN, AND A 1.5-3 COIL WAS SUCCESSFULLY DETACHED AND IMPLANTED . ADDITIONAL COILS, INCLUDING AN APB-1-2-3D AND AN APB-1-1-HX, WERE SEQUENTIALLY PLACED, ACHIEVING A DENSE EMBOLIZATION UPON ANGIOGRAPHY. THE PROCEDUREWAS THEN COMPLETED. THE COIL WAS STUCK IN THE DISTAL SECTION OF THE CATHETER. THERE WAS NO DAMAGE TO THE CATHETER. 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 OPHTHALMIC ARTERY ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359618 ↗
• MalfunctionMar 19, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, THE CATHETER ENTERED THE ANEURYSM CAVITY AND THE DELIVERED COIL COULD NOT BE DETACHED. AFTER MULTIPLE ATTEMPTS, THE CATHETER WAS REMOVED FROM THE BODY. AFTER CHECKING THE ENTIRE SYSTEM, IT WAS FOUND THAT THE CATHETER WAS KINKED IN THE PROXIMAL SECTION. THERE WAS COIL NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER TWO TIMES. THE PHYSICIAN TRIED ANOTHER INSTANT DETACHER ONCE. THERE WERE TWO MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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 CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR INTRACRANIAL ANEURYSM EMBOLIZATION TREATMENT OF A SACCULAR, UNRUPTURED LEFT C7 ANEURYSM WITH A MAX DIAMETER OF 3.3 MM AND A 2.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 4.75MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643817 ↗
• MalfunctionOct 2, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS SHAPED AFTER NORMAL HYDRATION, AND REACHED THE LESION. AFTER THE SPRING COIL WAS HYDRATED NORMALLY, IT WAS READY FOR FILLING. AFTER PART OF THE SPRING COIL ENTERED THE MICROCATHETER, IT COULD NOT ENTER AGAIN. WHEN THE SPRING COIL WAS WITHDRAWN, IT WAS FOUND THAT IT WAS STUCK IN THE MICROCATHETER. AFTER THE SPRING COIL WAS WITHDRAWN, IT HAD BEEN STRETCHED, SO REPLACED WITH THE MICROCATHETER AND SPRING COIL OF THE SAME MODEL, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED PER 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 SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 2MM AND A NECK DIAMETER OF 1.9MM. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 7MM DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE CAUSE OF THE STRETCH WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352050 ↗
• MalfunctionAug 26, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT REGARDING THE ECHELON 10 MICROCATHETER, THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED. THERE WERE 2 ATTEMPTS MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED WITH THE COIL. THERE WAS NO¿PUSHWIRE¿DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065592 ↗
• MalfunctionJun 18, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE WITH THE ECHELON CATHETER AND WAS FOUND STRETCHED. THE AVIGO GUIDEWIRE ALSO ENCOUNTERED RESISTANCE IN THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 2.3 MM AND A 1.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING COILING OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE PHYSICIAN TOOK THIS AS 1ST COIL. BUT AFTER PUSHING ALMOST COMPLETE LENGTH OF THIS COIL, HE FELT SEVERE RESISTANCE. WHILE REMOVING THIS COIL FROM ECHELON-10 MICROCATHETER, THIS COIL STRETCHED. THEN PHYSICIAN TOOK ANOTHER APB-2-4-3D-ES COIL TO START THIS COILING CASE. IT WAS REPORTED THE COIL STRETCHED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THERE WAS A CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE DAMAGE/STRETCHED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. IT WAS REPORTED THE PHYSICIAN TOOK THIS AVIGO GUIDEWIRE & ECHELON-10 MICROCATHETER FOR COILING OF AN ACOM ANEURYSM. WHILE PUSHING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562057 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED AND THAT THE CATHETER LEAKED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5.13MM AND A 3.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20MM. IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION, THE COIL WAS DELIVERED THROUGH THE MICROCATHETER, AND THE COIL AUTOMATICALLY DETACHED ITSELF IN THE MICROCATHETER. THE WHOLE PART WAS REMOVED AND REPLACED WITH A NEW ONE. THE COIL WAS WITHDRAWN FROM THE BODY INTEGRALLY WITH 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. 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. ADDITIONALLY, IT WAS REPORTED THAT THE CATHETER LEAKED IN THE DISTAL SECTION. THE CATHETER WAS INSPECTED OR TESTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191612 ↗
• MalfunctionMar 25, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. THERE WERE NO ISSUES WITH THE CATHETER. THE INSTANT DETACHER LOT NUMBER WAS B274208. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968569 ↗
• MalfunctionDec 27, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT IN AN ANEURYSM COILING CASE, THE ID-1-5 USED TO DETACH COIL DIDN'T WORK, THEN MANUAL DETACHMENT WAS PERFORMED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE ANEURYSM WAS SMALL, SACCULAR, DOME-2.5, HEIGHT-6, AICA ANEURYSM. VESSEL TORTUOSITY WAS SEVERE. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. THERE WERE 7 ATTEMPTS MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THERE WAS 1 ATTEMPT MADE TO DETACH THE COIL USING THE MANUAL METHOD. THE COIL WAS A MEDTRONIC DEVICE; AXIUM PRIME, LOT::226556149,227008032 227052961. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399223 ↗
• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE PHYSICIAN STRUGGLED TO UNSHEATHE THE AXIUM COILS. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430334 ↗
• MalfunctionJun 19, 2023Unintended Movement; Unintended Movement

  NEW INFORMATION RECEIVED. THAT AFTER, REPLACING THE EP STENT ASSIST. THE COIL WAS IMPLANTED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158271 ↗
• MalfunctionMay 8, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED DESPITE TRYING MORE THAN ONE INSTANT DETACHER (ID). THE COIL WAS REMOVED AND REPLACED. THE REPLACEMENT COIL WAS USED WITHOUT ISSUE. THERE WAS NO APPARENT HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887999 ↗
• MalfunctionApr 20, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT COIL PREMATURE DETACHMENT OCCURRED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED ANEURYSM OF THE LEFT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 3.2 X 3.5MM AND A 2.3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT BEFORE THE SURGERY, THE SURGEON FOUND THAT THE SPRING COIL PUSH ROD WAS RELATIVELY BENT, AND SURGEON WAS A LITTLE CONFUSED. THE SURGEON WAS WORRIED ABOUT THE QUALITY OF THE COIL.  THEN PUSHED THE SPRING COIL OUT OF THE SHEATH ON THE ASEPTIC OPERATING TABLE FOR OBSERVATION, AND THE SPRING COIL WAS COMPLETELY PUSHED OUT, AND THE SPRING COIL IMMEDIATELY FELL OFF THE STERILE TABLE. THE SURGEON EMPHASIZED THAT IT WAS A PRODUCT QUALITY ISSUE, WHICH NEEDED TO BE HANDLED AS A PRODUCT QUALITY COMPLAINT. THE COIL WAS NOT IMPLANTED IN THE HUMAN BODY, UNEXPECTED DETACHMENT FOUND IN VITRO. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS BENT OR BROKEN AND WAS NOT DONE ON PURPOSE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775938 ↗
• MalfunctionApr 6, 2023Therapy Delivered to Incorrect Body Area; Stretched; Therapy Delivered to Incorrect Body Area; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ANOTHER COIL WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691371 ↗
• MalfunctionMar 24, 2023Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED NO INTERVENTION HAS BEEN TAKEN. THE PATIENT CONTINUES TO HAVE NUMBNESS IN HER RIGHT LEG AND MILD WEAKNESS. NO MEDICAL INTERVENTION WAS OFFERED AT THE DISCRETION OF THE INITIAL PHYSICIAN.

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 16615075 ↗
• MalfunctionDec 2, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO PROBLEMS PRIOR TO THE NON-DETACHMENT, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE. THE COIL WAS WITHDRAWN AFTER IT WAS FOUND THAT IT COULD NOT BE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15901137 ↗
• MalfunctionOct 25, 2022Separation Failure; Separation Failure

  NEW INFORMATION WAS RECEIVED. THE CAUSE OF THE COIL NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL DETACHMENT THE DOCTOR TRIED TO DETACH THE COIL USING THE INSTANT DETACHER OVER THREE TIMES AND MANUAL DETACHMENT. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667399 ↗
• InjuryAug 16, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED AND THE PUSHWIRE SEPARATED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE BA-TOP. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE COIL REACHED THE DETACHED ZONE AN ATTEMPT WAS MADE TO DETACH IT USING THE INSTANT DETACHER (ID), BUT IT DID NOT DETACH. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE ID, AND ONE MANUAL DETACHMENT ATTEMPT WAS MADE. ANOTHER ID WAS NOT USED. A BREAKAGE OCCURRED WHEN THE DELIVERY WIRE WAS ABOUT TO BE PULLED, BUT IT WAS PULLED OUT AS IS. AS IT WAS BROKEN, A FEW CENTIMETERS OF DELIVERY WIRE REMAINED INSIDE THE PATIENT'S BODY, BUT IT WAS SAID THERE WAS NO EFFECT ON THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A 7FR MEDIKIT SUPER SHEATH, FUBUKI 7FR GUIDE CATHETER, HEADWAY 17 MICROCATHETER, AND A CHIKAI 14 GUIDEWIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15234501 ↗
• MalfunctionAug 10, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS STUCK IN THE DISTAL SECTION ECHELON MICROCATHETER AND THE AXIUM FAILED TO DETACH. DURING THE EMBOLIZATION PROCESS OF THE SPRING COIL, STUCK IN THE MICROCATHETER, COULD NOT BE DETACHED AND RECOVERED. FINALLY, IT WAS WITHDRAWN FROM THE BODY TOGETHER WITH THE MICROCATHETER. THE MICROCATHETER WENT UPPER AGAIN. THE CATHETER WAS NOT DAMAGED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES. THE PHYSICIAN DID NOT TY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT TO DETACH VIA A HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING SEGMENT ANEURYSM. THE MAX DIAMETER WAS 4.7MM AND THE NECK DIAMETER WAS 2MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204582 ↗
• MalfunctionJul 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS PREMATURELY DETACHED IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S BLOOD FLOW WAS HIGH, AND THEIR VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED WITH THE FIRST COIL, BUT NOT THE SECOND. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118094 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE FOURTH COIL USED IN THE PROCEDURE, AN AXIUM PRIME COIL, DETACHED SPONTANEOUSLY WITHIN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. IT WAS NOTED THAT THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO HARM OR INJURY TO THE PATIENT. OTHER EVENT INFORMATION WAS NOT KNOWN AT TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167128 ↗
• MalfunctionNov 4, 2020Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT WHEN THE AXIUM COIL WAS TAKEN OUT OF THE PACKAGING, IT WAS BENT ON THE PROXIMAL SEGMENT OF THE DELIVERY WIRE. THE PHYSICIAN DECIDED TO USE ANOTHER COIL OF THE SAME SIZE FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT INDICATED WITH THIS EVENT. THE PHYSICIAN NOTED THAT THERE NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING, THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Patient Involvement

  MAUDE report 10788377 ↗
• MalfunctionSep 28, 2020Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO THE COIL NON-DETACHMENT NO ISSUES WERE ENCOUNTERED, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE AFTER REMOVAL FROM THE PATIENT. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10596845 ↗
• MalfunctionJun 30, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH. TWO ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. THE PHYSICIAN ATTEMPTED TO DETACH ONCE USING THE HYPOTUBE, AND IT STILL WOULD NOT DETACH. SUBSEQUENT COILS WERE IMPLANTED USING THE SAME MICROCATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A STRYKER MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10210691 ↗
• MalfunctionJun 5, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE AXIUM COIL NON-DETACHMENT ISSUE DID NOT CONTRIBUTE TO THE PATIENT DEATH. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS. NO ISSUES WERE ENCOUNTERED PRIOR TO NON DETACHMENT, THE PUSHWIRE WAS FRAYED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10122989 ↗
• MalfunctionMay 22, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS BROKEN. THE BROKEN COIL HAD NOT BEEN RELEASED AND WAS NEVER IN THE PATIENT. THE COIL WAS REPLACED. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. 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 MIDDLE CEREBRAL TERRITORY (M1M2) AND A SEVERE SEGMENTAL VASOSPASM IN ALL OF M1 AND THE HOMOLATERAL SILVIANA TEMPORAL BRANCH. THE MAX ANEURYSM DIAMETER WAS 4 MM. THE NECK DIAMETER WAS 3 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10083235 ↗