AxiumTM APB-2.5-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00847536021204), received between Apr 1, 2019 and May 5, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 5, 2025Retraction Problem; Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING THE AXIUM COIL EMBOLIZATION PROCEDURE FOR A 4MM A-COM ANEURYSM, THE COIL WAS INSERTED THROUGH THE NON-MEDTRONIC MICROCATHETER (SL-10) AND DETACHED WITHOUT ANY PROBLEMS AND IMPLANTED IN THE ANEURYSM. HOWEVER, WHEN AN ATTEMPT WAS MADE TO RETRACT AND REMOVE THE DELIVERY WIRE, INTERFERENCE WITH THE NON-MEDTRONIC MICROCATHETER (SL-20) PREVENTED THE RETRIEVAL OF ONLY THE DELIVERY WIRE. AS A RESULT, THE NON-MEDTRONIC MICROCATHETER (SL-10) WAS INADVERTENTLY REMOVED ALONG WITH THE DELIVERY WIRE. ONCE THE NON-MEDTRONIC MICROCATHETER (SL-10) WAS REMOVED EXTERNALLY, THE DELIVERY WIRE WAS ABLE TO BE EXTRACTED WITHOUT ISSUE. THE FACILITY'S OPINION IS THAT THERE WAS A DEFECT WITH THE DELIVERY WIRE OF THE COIL. 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 21958988 ↗
• MalfunctionNov 30, 2023Detachment of Device or Device Component; Migration; Physical Resistance/Sticking; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE RESISTANCE WAS IN THE MICROCATHETER HUB. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER USED WAS A STRYKER SL-10. THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE. THIS WAS THE FIRST COIL. THERE WERE 2 COILS THAT WERE SUCCESSFULLY IMPLANTED. "ANZ" REFERS TO ANEURYSM.

  Patient problems: Failure of Implant

  MAUDE report 18241132 ↗
• MalfunctionSep 15, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS AXIUM COIL NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER THREE TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. THE PHYSICIAN TRIED 2 TIMES WITH THE SECOND INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THE MANUAL METHOD WAS ATTEMPTED 2 TIMES. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756437 ↗
• MalfunctionJun 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE MICROCATHETER DURING DELIVERY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED AMORPHOUS ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3.7MM AND THE NECK DIAMETER WAS 1.2MM. 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). TWO COILS HAD ALREADY BEEN DEPLOYED SUCCESSFULLY. THE THIRD COIL WAS NOT ADVANCING SMOOTHLY IN THE MIDDLE SEGMENT OF THE MICROCATHETER; THERE WAS RESISTANCE. THE DOCTOR TRIED TWICE TO DELIVER THE COIL BUT CONTINUED TO FEEL RESISTANCE SO THE COIL WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO DAMAGE NOTED TO THE CATHETER OR THE COIL. THERE WAS NO HARM OR INJURY TO THE PATIENT. 2022-09-17 EMAIL (FOR, REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL COME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238516 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THE RESISTANCE WAS LOCATED AT THE CATHETER HUB. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE ECHELON CATHETER MODEL:105-5091-150, LOT #:B452773.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172893 ↗
• MalfunctionSep 14, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL 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 15420291 ↗
• MalfunctionSep 9, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT PERFORATED THE VESSEL AND FAILED TO DETACH. THAT PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2.5MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. A DOUBLE CATHETER TECHNIQUE WAS USED. AFTER PLACING 2 PRIOR COILS, THE AXIUM COIL WAS THE THIRD TO BE USED BUT IT PERFORATED OUTSIDE THE ANEURYSM SO IT WAS REMOVED AND DELIVERED USING THE OTHER CATHETER. DETACHMENT WAS ATTEMPTED BUT THE COIL COULD NOT BE DETACHED. AFTER FAILED DETACHMENT, FORCED WITHDRAWAL WAS ATTEMPTED BUT THE COIL STILL FAILED TO DETACH. EVENTUALLY, THE COIL MASS WAS HELD DOWN WITH A SNARE AND THE DELIVERY WIRE WAS PULLED AND THE COIL WAS FINALLY DETACHED. THERE WAS NO HARM TO THE PATIENT'S HEALTH.

  Patient problems: Perforation

  MAUDE report 15393259 ↗
• MalfunctionNov 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. IT WAS REPORTED THE DEVICE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). WHEN UNCAPPING THE COIL IN THE VAT OF SALINE FOR HYDRATION, THE COIL DETACHED FROM THE DELIVERY WIRE AND BECAME UNUSABLE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760201 ↗
• MalfunctionOct 6, 2021Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO DETACHMENT, AN ATTEMPT WAS MADE TO PLACE THE COIL WHILE THE PULSERIDER WAS STILL IN PLACE. HOWEVER, THE SHAPE DID NOT MATCH, AND THE COIL BECAME ENTANGLED WITH THE PULSERIDER WHEN ATTEMPTING TO RETRIEVE IT. THE DEVICES WERE RETRIEVED TOGETHER. 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. ADDITIONAL INFORMATION CLARIFIED THAT THE COIL CAME OUT OF THE ANEURYSM. THERE WAS NO DAMAGE TO THE COIL PRIOR TO BECOMING STUCK ON THE PULSERIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586076 ↗
• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PROCEDURE WAS COMPLETED BY REMOVING THE MICROCATHETER AND RECATHETERIZED THE ANEURYSM. IT WAS NOTED THAT THEY JUST TRIED TO MOVE THE SPRING BACK INSIDE THE MICROCATHETER A LITTLE AND THEN REALIZED IT HAD DETACHED. THE COIL WAS NOT IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497207 ↗
• MalfunctionAug 27, 2021Difficult or Delayed Positioning; Separation Failure; Detachment of Device or Device Component; Difficult or Delayed Positioning; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT A NON-MEDTRONIC COIL WAS FIRST BEING USED BUT THE SURGICAL TEAM REALIZED DURING DELIVERY OF THE COIL THAT THEY DID NOT HAVE A DETACHER FOR THAT COIL SO IT WAS REMOVED AND DISCARDED. THE PREVIOUSLY REPORTED EVENTS THEN OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378263 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD EARLY DETACHMENT AND DAMAGE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM MAXIMUM DIAMETER IS 3MM AND NECK DIAMETER IS 3MM. VESSEL TORTUOSITY WAS SEVERE.  THE DEVICES WERE PREPARED ACCORDING TO THE INDICATION FOR USE (IFU). AFTER INSERTING THIS PRODUCT, IT WAS TRIED TO PULL ONCE AT THE REMAINING 1CM, BUT THERE WAS NO RESISTANCE AND THE COIL DID NOT MOVE DUE TO UNRAVELING OR EARLY DETACHMENT. CONFIRMED BY CONBEAM CT, AND IT WAS DETERMINED TO BE EARLY DETACHMENT. AS THE COIL DEVIATED OUTSIDE THE ANEURYSM, AN ATLAS STENT WAS USED IN AN EMERGENCY TO RESTRAIN THE COIL. THE COIL WAS RELOCATED ONCE. WHEN IT WAS TRIED TO RELOCATE AND PULL, IT HAD EARLY DETACHMENT AT THAT TIME. THERE WAS NO RESISTANCE DURING DELIVERY AND THEY DID NOT TRY TO DETACH THE COIL. DURING THE PROCEDURE, THE FLUSH WAS PERFORMED WITHOUT INTERRUPTION. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: ATLAS STENT, CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338506 ↗
• MalfunctionFeb 8, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED A CAUSE OF THE COIL BREAK COULD NOT BE DETERMINED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297760 ↗
• MalfunctionOct 30, 2020Difficult or Delayed Positioning; Display or Visual Feedback Problem; Difficult or Delayed Positioning; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION CLARIFIED THAT THE COIL WAS RETRIEVED AND DISCARDED. THE CASE WAS OBSERVED DURING THE PROCEDURE, AND NO ADVERSE EVENT OCCURRED.

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

  MAUDE report 10763429 ↗
• MalfunctionOct 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY, THE SURGEON NORMALLY PUSHED THE COIL TO ADJUST THE POSITION, AND THE COIL SUDDENLY DETACHED ON ITS OWN. AS A RESULT, THE COIL WAS DETACHED IN THE WRONG LOCATION. THE COIL WAS ABLE TO BE RETRIEVED BY THE TAIL END TO WITHDRAWN IT FROM THE PATIENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED, NO FRICTION DURING DELIVERY, NO DETACHMENT ATTEMPTS WERE MADE, THERE WAS NO DAMAGE TO THE PUSHWIRE, NO ROTATION WAS PERFORMED, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. 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 OF THE BASILAR ARTERY WITH A MAX DIAMETER OF 2 MM AND A 1.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

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

  MAUDE report 10736518 ↗
• MalfunctionOct 21, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THREE COILS WERE IMPLANTED WITH NO ISSUES. THE REPORTED AXIUM COIL WAS THE FOURTH COIL USED. AFTER DELIVERY, DETACHMENT WAS PERFORMED THREE TIMES WITH THE INSTANT DETACHER, BUT THE COIL FAILED TO DETACH. THE BREAK INDICATOR WAS BROKEN AND PULLED, BUT THE COIL STILL FAILED TO DETACH. THE PHYSICIAN DECIDED TO RETRIEVE THE COIL, BUT WHEN ABOUT 3 CM OF THE DEVICE WAS RETRIEVED, THE COIL DETACHED INSIDE THE MICROCATHETER. THE PUSHWIRE WAS REMOVED, AND AN ATTEMPT WAS MADE TO DELIVER THE COIL TO THE ANEURYSM WITH THE GUIDEWIRE. THE COIL WAS RETURNED TO THE ANEURYSM AUTONOMOUSLY WHEN THE WIRE WAS INSERTED ABOUT 100 CM. AFTER THAT, THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. IT WAS NOTED A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND NO RESISTANCE WAS EXPERIENCED DURING DELIVERY. 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 SUBARACHNOID HEMORRHAGE DUE TO A SACCULAR, RUPTURED ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH A MAX DIAMETER OF 5 MM AND A 2.5 MM NEC

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

  MAUDE report 10714320 ↗
• MalfunctionOct 12, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A 2.5 MM SACCULAR ANEURYSM ON BA-SCA WITH MODERATE VESSEL TORTUOSITY. THE INSTANT DETACHER WAS TAKEN OUT OF THE PACKAGE, AND THREE ATTEMPTS WERE MADE TO DETACH THE REPORTED COIL, BUT IT FAILED. THE MANUAL DETACHMENT METHOD WAS PERFORMED ONCE, BUT THE COIL STILL DID NOT DETACH. IT WAS STATED THERE MIGHT BE A CAUSE IN THE COIL, BUT IT WAS DETACHED WHEN TRYING TO REMOVE THE COIL. THE DETACHED COIL WAS IMPLANTED BY USING THE PUSHWIRE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DAMAGE OBSERVED TO THE COIL PUSHWIRE. 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. THERE WAS NO ABNORMALITY IN THE PACKAGE OF THE INSTANT DETACHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10662865 ↗
• MalfunctionSep 15, 2020Detachment of Device or Device Component; Material Deformation; Activation Failure; Detachment of Device or Device Component; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 4.2 MM AND A 1.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT WHILE DEPLOYING THE AXIUM COIL, IT BECAME PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN HAD TO PULL THE MICROCATHETER OUT FROM THE ANEURYSM, AND THE DETACHED COIL WAS REMOVED BY INSERTING A 0.014" GUIDEWIRE. THE DETACHED COIL WAS LOST, AND WHILE PACKING THE PUSHWIRE OF THE COIL, IT ACCIDENTALLY BROKE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, NO REPOSITIONING, NO DETACHMENT ATTEMPTS MADE, NO ROTATION OF THE PUSHWIRE, AND A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. 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.

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

  MAUDE report 10536109 ↗
• MalfunctionDec 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ACOM ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 1.7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO DELIVER THE COIL, IT BECAME PREMATURELY DEPLOYED. IT WAS UNKNOWN WHERE THE COIL WAS, BUT NO SURGICAL/MEDICAL INTERVENTION WAS REQUIRED, THE PUSHWIRE WAS NOT BENT/BROKEN, THERE WAS NO FRICTION DURING DELIVERY, THE COIL WAS NOT REPOSITIONED, THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL OR ROTATE THE PUSHER, AND A CONTINUOUS FLUSH WAS ADMINISTERED. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9460468 ↗
• MalfunctionNov 25, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT AFTER POSITIONING THE COIL, DETACHMENT WAS ATTEMPTED BUT IT FAILED. THE DEVICE WAS RETRIEVED. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. A SECOND DETACHER WAS NOT USED, AND IT IS UNKNOWN IF MANUAL DETACHMENT WAS ATTEMPTED (ASKED UNKNOWN). THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT INTERNAL CAROTID ANEURYSM THAT WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 5MM AND THE NECK WAS 2MM. THE DEVICES WERE PREPARED AND USED PERTHE INSTRUCTIONS FOR USE (IFU). THE VESSEL ANATOMY WAS REPORTED TO HAVE BEEN MODERATE IN TORTUOSITY. NO PATIENT INJURY OCCURRED. ANCILLARY DEVICE: SL-10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9369039 ↗
• MalfunctionApr 11, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS COIL PUSHER NON DETACHMENT. IT WAS STATED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 3 TIMES WITH THE INSTANT DETACHER, AND 3 TIMES VIA HYPOTUDE/MANUAL DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM WITH UNKNOWN DIMENSIONS. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8505709 ↗
• MalfunctionApr 1, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING COILING OF AN 8MM ANEURYSM. THE PATIENT¿S VASCULATURE WAS MILD IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, 10 COILS HAD BEEN PLACED IN THE ANEURYSM. AN 11TH COIL (AXIUM PRIME) WAS ATTEMPTED TO BE PLACED. AT DETACHMENT, THE COIL COULD NOT BE DETACHED. THE INSTANT DETACHER USED WAS NEW AND HAD BEEN USED 2-3 PRIOR TO NON-DETACHMENT. MANUAL DETACHMENT WAS ATTEMPTED ONCE. NO FORCE WAS APPLIED TO PULL THE WIRE. THE COIL WAS REMOVED. THERE WAS NO DAMAGE TO THE PUSHWIRE. THE PROCEDURE WAS COMPLETED USING A NEW COIL. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471405 ↗