Axium Prime Detachable Coil System APB-3-8-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000313746), received between Feb 24, 2022 and May 18, 2026 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL EXPERIENCED STRETCHING DURING IMPLANTATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE C7 SEGMENT WITH A MAX DIAMETER OF 5 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 DURING THE IMPLANTATION OF THE SPRING COIL, STRETCHING OCCURRED. REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NOT ANY ISSUES THAT RESULTED IN DAMAGE AND THAT THE CAUSE OF THE STRETCHING WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203162 ↗
• MalfunctionMar 26, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST COIL SELECTED WAS AN AXIUM PRIME BARE COIL (APB-3-6-3D-ES), WHICH WAS HYDRATED AND DELIVERED THROUGH AN ECHELON 10 MICROCATHETER. RESISTANCE WAS ENCOUNTERED DURING COIL DELIVERY. DURING THE DETACHMENT PROCESS, IT WAS FOUND THAT THE COIL WAS VISIBLY KINKED WITHIN THE MICROCATHETER, SO THE OPERATOR PREPARED TO WITHDRAW THE COIL. UPON WITHDRAWAL, THE COIL WAS ACCIDENTALLY DETACHED, AND THE OPERATOR USED A GUIDEWIRE TO PUSH THE COIL OUT OF THE MICROCATHETER. AS THERE WAS NO COIL OF THE SAME MODEL AVAILABLE, THE OPERATOR REPLACED IT WITH AN APB-3-8-3D-ES. AGAIN, RESISTANCE WAS ENCOUNTERED DURING DELIVERY, AND UPON WITHDRAWAL, IT WAS FOUND THAT THE PUSHROD WAS KINKED. THE COIL WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. WHEN USING THE ECHELON 10 MICROCATHETER TO DELIVER COILS FROM OTHER BRANDS, NO EXCESSIVE RESISTANCE WAS ENCOUNTERED SO IT WAS THOUGHT THAT THE ISSUE WAS WITH THE COIL, HOWEVER, UPON REVIEW, IT WAS FOUND THAT THERE HAD BEEN SEVERAL RECENT CASES IN THE REGION WHERE COIL DELIVERY WITH THE ECHELON MICROCATHETER WAS DIFFICULT OR THE COIL COULD NOT BE COME OUT. IT WAS SUSPECTED THAT THE ISSUE MAY B E RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707129 ↗
• MalfunctionFeb 19, 2026Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IT WAS CLARIFIED THAT, "AFTER BEING TAKEN OUT FROM THE PACKAGING AND HYDRATION, THE DEVICE WAS DELIVERED THROUGH THE PROTECTIVE SHEATH, BUT COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387922 ↗
• MalfunctionAug 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED RESISTANCE AND BECAME STUCK IN THE DISTAL SECTION OF THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE UPPER TRUNK MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DOCTOR WAS PERFORMING AN EMERGENCY ANEURYSM INTERVENTIONAL SURGERY ON A PATIENT WITH A RUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM AND BLEEDING. THE PATIENT CAME TO HOSPITAL FOR EMERGENCY. AFTER ESTABLISHING THE PATHWAY, A 5-15-3D QC COIL WAS DELIVERED THROUGH THE ECHELON10 MICROCATHETER. WHEN DELIVERING THE SECOND ES COIL, APB-3-8-3D-ES, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, PREVENTING IT FROM REACHING THE ANEURYSM. AFTER TWO ATTEMPTS, THE SURGEON SWITCHED TO A SMALLER ES COIL, APB-2.5-4-HX-4S, BUT IT STILL FACED CONSIDERABLE RESISTANCE, PREVENTING PROPER PLACEMENT. TO EXPEDITE TREATMENT, THE SURGEON CHOSE NOT TO REPLACE THE ACCESS CATHETER AND INSTEAD USED A COIL FROM ANOTHER MANUFACTURER, WHICH WAS SUCCESSFULLY DELIVERED, CONCLUDING THE PROCEDURE. THE CATHETER WAS NOT DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804694 ↗
• MalfunctionMay 14, 2025Inadequacy of Device Shape and/or Size; Stretched; Unintended Movement; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Stretched; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT CATHETER RESISTANCE OCCURRED IN THE MIDDLE SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS A KINK IN THE CATHETER OBSERVED AFTER REMOVAL. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018432 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE WHILE PUSHING THE COIL IN THE MICROCATHETER. WHILE REMOVING, THE COIL GOT PREMATURELY DETACHED. THERE WAS PUSHER KINK/BROKEN. THERE WAS FRICTION DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION ON THE DEVICE WAS THE IMPLANT COIL. 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, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4X5 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708061 ↗
• MalfunctionMar 27, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM SPRING COIL WAS STRETCHED. IT WAS PLANNED TO PERFORM AN INTRACRANIAL ANEURYSM EMBOLIZAT ION SURGERY. THE SPRING COIL ENCOUNTERED RESISTANCE DURING THE PUSHING AND COULD NOT BE PUSHED. AFTER THE SPRING COIL WAS WITHDRAWN, IT WAS FOUND THAT THE SPRING COIL WAS STRETCHED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. THE PATIENTS BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL; IT WAS JUST FOUND TO BE STRETCHED. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. THE CATHETER WAS A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704666 ↗
• MalfunctionFeb 18, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY, THERE WERE ISSUES WITH THE AXIUM PRIME BARE 3D COIL. THE COIL ENCOUNTERED SIGNIFICANT RESISTANCE WHILE BEING PUSHED THROUGH THE MICROCATHETER AND BECAME STUCK IN THE MIDDLE OF THE CATHETER. UPON WITHDRAWAL, IT WAS OBSERVED THAT THE COIL HAD STRETCHED. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 6 MILLIMETERS AND A NECK DIAMETER OF 3 MILLIMETERS, WITH NORMAL BLOOD FLOW AND MINIMAL VESSEL TORTUOSITY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS NOT REPOSITIONED, AND THE CATHETER WAS NOT DAMAGED. THE COIL WAS DAMAGED AT THE IMPLANT COIL LOCATION. THE PRODUCT WAS NEVER IMPLANTED AND WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE/STRETCH WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRO DUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395430 ↗
• MalfunctionNov 15, 2024Stretched; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DISTRIBUTOR HAS CONFIRMED WITH THE CUSTOMER THAT IT HAPPENED DURING THE ONYX EMBOLIZATION PROCEDURE. THE COIL WAS FIRST FILLED WITH MARATHON, AND THEN THE CATHETER TIP WAS FOUND TO HAVE FALLEN OFF WHEN THE GLUE WAS APPLIED. AFTER THE HOSPITAL RETURNED THE PRODUCT TO THE WAREHOUSE, THE DISTRIBUTOR TREATED IT WITH IODOPHOR AND SENT IT OUT BY EXPRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698914 ↗
• MalfunctionAug 15, 2024Stretched; Stretched

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19993714 ↗
• MalfunctionJul 19, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PUSHER DISTAL SEGMENT WAS KINKED. IT WAS REPORTED THAT THE COIL WAS KINKED/DAMAGED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS LOCATED ON THE DISTAL SEGMENT OF THE PUSHWIRE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN EXCELSIOR SL-10 45 AND HEADWAY 17 MICROCATHETER, SYNCHRO 14 GUIDEWIRE, AND LVIS EVO. ADDITIONAL INFORMATION WAS RECEIVED THAT VESSEL TORTUOSITY WAS NORMAL. THE PROCEDURE WAS COMPLETED "GOOD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785898 ↗
• MalfunctionJun 25, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS FOUND TO BE STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY TERMINAL WITH A MAX DIAMETER OF 4.5 MM AND A 3.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT INTERNAL CAROTID ARTERY TERMINAL ANEURYSM, MICROCATHETER IN PLACE, STENT-ASSISTED EMBOLIZATION, DETACHABLE SPRING COIL APB-3-8-D-3D WAS PUSHED OUT FROM THE PROTECTIVE SHEATH AND FOUND TO HAVE BEEN STRETCHED AND COULD NOT BE USED NORMALLY. REPLACEMENT OF THE SAME MODEL OF SPRING COIL, SUCCESSFUL DETACHMENT. THE OPERATION ENDED SUCCESSFULLY. 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. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE COIL STRETCH WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606793 ↗
• MalfunctionFeb 5, 2024Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS OBSERVED TO HAVE A KINK/DAMAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT MIDDLE CEREBRAL ARTERY (M1) WITH A MAX DIAMETER OF 7.2 MM AND A 4.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM SPRING COIL COULDN'T BE IMPLANTED PROPERLY DURING THE IMPLANTATION PROCESS. IT WAS REPORTED THE COIL WAS KINKED/DAMAGED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE/STRETCHED LOCATION ON THE DEVICE WAS ON THE IMPLANT COIL. THE PHYSICIAN REPOSITIONED THE COIL TWO TIMES DURING THE PROCEDURE. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. IT WAS NOTED THAT THE TIP END OF THE SPRING COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646436 ↗
• MalfunctionJul 20, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE DETACHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. 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 MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 3MM AND A 1MM 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 17363036 ↗
• MalfunctionJun 13, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ECHELON10 CATHETER,MODEL:105-5 091-150,LOT#:B384499.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118114 ↗
• MalfunctionDec 21, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED BASILAR TIME ANEURYSM, THE AXIUM COIL WAS DELIVERED BUT FAILED TO DETACH WITH THE INSTANT DETACHER. THE PHYSICIAN REMOVED THE WHOLE SYSTEM SYSTEM CAREFULLY. THE PATIENT OUTCOME INFORMATION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022894 ↗
• MalfunctionNov 21, 2022Break; Stretched; Break; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5.4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON HAD NOT YET PERFORMED THE OPERATION RELATED TO THE DETACHMENT OF THE SPRING COIL, THE SPRING COIL WAS STRETCHED. THE SURGEON THEN USED A MICRO-GUIDE WIRE TO TAKE OUT THE STRETCHED SPRING COIL, THE SPRING COIL WAS COMPLETELY TAKEN OUT AND NOT IMPLANTED. THE SPRING COIL STRETCHED LONG AND THE DOMESTIC PRODUCT WAS TAKEN OUT. IT OCCURRED THAT IT WAS PULLED TO BE BROKEN OUTSIDE THE PATIENT'S BODY. IT WAS UNKNOWN THAT HOW MANY STRETCHED SPRING COILS WERE WITHDRAWN. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. IT WAS UNKNOWN IF THE PUSHWIRE WAS 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 DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833889 ↗
• MalfunctionSep 22, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE WHEN THE AXIUM PRIME COIL WAS PUSHED FROM THE PROTECTIVE SHEATH INTO THE MICROCATHETER THE RESISTANCE WAS LARGE. INSPECTION FOUND THAT THE COIL HAD BEEN DETACHED AND DID NOT ENTER THE BODY. AFTER THE COIL WAS REPLACED THE SURGERY WENT SMOOTHLY. 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 A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 4*6MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464874 ↗
• MalfunctionFeb 24, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DID NOT DETACH. THE PATIENT WAS TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER OF THE ANEURYSM WAS 5.88MM AND THE NECK DIAMETER WAS 3.26MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  ENDOVASCULAR TREATMENT OF ANEURYSM, COIL EMBOLIZATION WAS PERFORMED AFTER THE MICROCATHETER WAS DELIVERED IN PLACE. THE EMBOLIZATION WITH AXIUM PRIME COIL IN THE PREVIOUS SEQUENCE WAS NORMAL. WHEN APB-3-8-3D-ES/222520544 WAS USED FOR EMBOLIZATION, THE COIL WAS DELIVERED INTO THE ANEURYSM AND DETACHED MARKER AND THE MICROCATHETER MARKER FORMED AN INVERTED T AND WERE DETACHED NORMALLY, BUT THEY COULD NOT BE DETACHED. THE USE OF THE SPARE DETACHMENT AREA TO DETACH ALSO COULD NOT BE DETACHED. SO THE COIL WAS PUSHED OUT AND REPLACED WITH A NEW COIL FOR EMBOLIZATION, AND THE SUBSEQUENT COIL COULD BE DETACHED NORMALLY. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES. THE PHYSICIAN TRIED TO DETACH WITH A SECOND DETACHER 2 TIMES. THERE WERE TWO ATTEMPTS TO DETACH VIA A HYPOTUBE TWO TIMES. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589375 ↗