Axium Prime Detachable Coil System APB-1.5-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000313654), received between Aug 17, 2022 and Jun 30, 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.

• MalfunctionJun 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION OF AN ANEURYSM, AFTER THE MICROCATHETER WAS POSITIONED, A JOHNSON & JOHNSON 2.5¿5 COIL WAS SELECTED AND SUCCESSFULLY PUSHED IN. SUBSEQUENTLY, ANOTHER COIL OF THE SAME BRAND WAS SELECTED, BUT IT COULD NOT BE ADVANCED INTO THE MICROCATHETER. OTHER COILS, INCLUDING AXIUM PRIME (APB-1.5-2-3D-ES, APB-1.5-2-3D-ES, APB-1.5-3-3D-ES) AND SEVERAL OTHER BRANDS, WERE ATTEMPTED, BUT NONE OF THEM COULD BE PUSHED IN. THE PHYSICIAN WITHDREW THE COILS. THE MICROCATHETER WAS THEN REMOVED AND REPLACED WITH A NEW ONE, AFTER WHICH THE PROCEDURE WAS COMPLETED. RESISTANCE OCCURRED AT THE HUB OF THE CATHETER. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED 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 AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THE AXIUM COILS DID NOT E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666208 ↗
• MalfunctionJun 29, 2026Difficult or Delayed Positioning; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE AB HAD COIL PROTRUSION STRUTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LOCATED ON THE RIGHT INTERNAL CAROTID ARTERY, C7 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5.89MM AND A 3.66MM NECK DIAMETER. THE PARENT VESSEL WAS STATED TO BE THE RIGHT INTERNAL CAROTID ARTERY MEASURING AT 4.52MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE OPERATOR PLANNED TO TREAT THE PATIENT¿S ACUTELY RUPTURED ANEURYSM WITH A STAND-ALONE COIL EMBOLIZATION, A SAB STENT WAS PREPARED IN CASE STENT ASSISTANCE WAS REQUIRED. DURING THE PROCEDURE, AN ECHELON MICROCATHETER WAS ADVANCED INTO THE ANEURYSM SAC, AND AFTER THE REBAR CATHETER WAS SELECTIVELY POSITIONED, INITIAL COIL FILLING WAS PERFORMED. THE COIL COULD NOT BE STABILIZED WITHIN THE ANEURYSM; THEREFORE, THE SAB STENT WAS DEPLOYED FOR ASSISTANCE, FOLLOWED BY COIL DELIVERY FOR ANEURYSM EMBOLIZATION. HOWEVER, THE COIL CONTINUED TO PROTRUDE AND HERNIATE INTO THE PARENT ARTERY. THE OPERATOR RETRIEVED THE COIL FOR ADJUSTMENT AND ATTEMPTED RE-EMBOLIZATION, BUT THE SAB STENT WAS STILL UNABLE TO EFFECTIVELY PREVENT COIL PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662004 ↗
• MalfunctionJun 29, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF AXIUM COILS THAT COULD NOT ADVANCE THROUGH A MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY C7 SEGMENT WITH A MAX DIAMETER OF 2.5MM AND A 0.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE MICROCATHETER MALFUNCTIONED, RESULTING IN INABILITY TO ADVANCE SUBSEQUENT COILS. AFTER REPLACING THE MICROC ATHETER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE REPORTED MICROCATHETER MALFUNCTION WERE IDENTIFIED. THE LOCATION OF ANY RESISTANCE WITHIN THE CATHETER (HUB, PROXIMAL, MIDDLE, OR DISTAL) COULD NOT BE DETERMINED. THE COIL EXITED THE INTRODUCER SHEATH SMOOTHLY, AND A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED PER IFU. IT IS UNKNOWN WHETHER ANY KINK OR DAMAGE WAS OBSERVED TO THE COIL OR THE CATHETER AFTER REMOVAL. THE CATHETER USED, I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660854 ↗
• MalfunctionApr 3, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE ECHELON MICROCATHETER CATHETER AND THE DEVICES WERE DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 2.2MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10MM DIAMETER. IT WAS REPORTED THAT THE ECHELON10 MICROCATHETER (MODEL: 145-5091-150, LOT NO: 0231382011) WAS USED AND POSITIONED. THE FIRST COIL SELECTED WAS APB-2-4-HX-ES (LOT NO: 229294003). DURING DELIVERY, LARGE RESISTANCE WAS FELT. UPON RETRIEVAL OF THE COIL FOR INSPECTION, IT WAS FOUND THAT THE COIL HAD STRETCHED. THE COIL WAS REPLACED WITH APB-2-3-3D-ES (LOT NO: 230744221). DURING DELIVERY, LARGE RESISTANCE WAS FELT, AND THE PUSH ROD KINKED IN THE MIDDLE SECTION DURING ADVANCEMENT. WHEN ATTEMPTING TO RETRIEVE IT FOR INSPECTION, IT WAS FOUND THAT THE MICROCATHETER HAD ALSO KINKED, SO THE DOCTOR HAD TO REMOVE BOTH FROM THE PATIENT'S BODY. IT WAS NOTED THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783537 ↗
• MalfunctionFeb 12, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR EMBOLIZATION CEREBRAL. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN.  IT WAS REPORTED THAT THE DOCTOR EXPERIENCED RESISTANCE OF THE ECHELON MICROCATHETER IN THE PASSAGE OF THE AXIUM COIL SPRINGS, CAUSING DEFECTS IN THEM. THE TWO COILS WERE STUCK IN THE SHEATH. ALSO THE CATHETER RESISTANCE WAS ENCOUNTERED WITHIN THE GUIDE CATHETER DURING THE PROCEDURE. IT IS UNKNOWN WHETHER THERE WAS ANY DAMAGE TO THE GUIDE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED IN THE HUB PASSAGE OF THE CATHETER. IT IS NOT KNOWN WHETHER THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK OR DAMAGE WAS OBSERVED ON EITHER THE COIL OR THE CATHETER AFTER REMOVAL. THE GUIDE CATHETER WAS NOT A MEDTRONIC PRODUCT, AND NO KINK OR DAMAGE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329282 ↗
• MalfunctionJul 18, 2025Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE CATHETER RESISTANCE WAS NOT DETERMINED. REGARDING THE CAUSE OF THE THREE USED COILS RESISTANCE AND CATHETER DAMAGE, THE SURGEON CONSIDERED IT TO BE A PROBLEM WITH THE QUALITY OF THE MICROCATHETER. THE COIL DAMAGE MAY HAVE BEEN CAUSED BY THE RESISTANCE OF THE MICROCATHETER DURING DELIVERY. THE CATHETER DAMAGE OBSERVED WAS KINKING. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE COIL DAMAGE OBSERVED WAS A BREAKAGE. THE COIL APB-1-1-HX-ES, LOT # 229175967 WAS ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545724 ↗
• MalfunctionApr 11, 2025Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE COIL STRETCH/BREAK/PREMATURE DETACHMENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF THERE WERE ANY ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. A STRYKER SL-10 CATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21828236 ↗
• MalfunctionFeb 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS STUCK IN THE ECHELON10 CATHETER. THE COIL COULDN'T BE PUSHED OUT OF THE MICROC ATHETER. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUSOITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS RESISTANCE LOCATED IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER USED WAS AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323912 ↗
• MalfunctionOct 10, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. REGARDING THE PREMATURELY DETACHED COIL, THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417563 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL EXPERIENCED RESISTANCE IN THE MIDDLE OF THE ECHELON 10 MICROCATHETER AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 7MM IN DIAMETER. IT WAS REPORTED THAT THE ECHELON10 MICROCATHETER WAS INSERTED TO REACH THE LESION SITE. THE FIRST SPRING COIL WAS A APB-3-6-3D-ES, WHICH WAS DELIVERED TO THE MICROCATHETER THROUGH THE Y VALVE AND SUCCESSFULLY REACHED THE LESION SITE AFTER HYDRATION. AFTER THE HOOP WAS SUCCESSFULLY FORMED, A APB-1.5-3-3D-ES COIL WAS SELECTED. WHEN THE SPRING COIL WAS PUSHED TO THE MIDDLE OF THE MICROCATHETER, THE PUSH RESISTANCE WAS OBVIOUS. THE SURGEON FOUND IN THE IMAGE THAT THE SPRING COIL WAS AUTOMATICALLY DETACHED. THE SURGEON THOUGHT THAT THERE WAS A QUALITY PROBLEM WITH THE SPRING COIL, SO THEY QUICKLY REMOVED THE MICROCATHETER AND THE SPRING COIL AT THE SAME TIME. THE SURGEON WAS WORRIED THAT THERE WAS ALSO A PROBLEM WITH THE MICROCATHETER, SO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088012 ↗
• MalfunctionAug 7, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PUSHWIRE WAS FOUND KINKED/BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY 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 NORMAL. IT WAS REPORTED THAT WHEN THE SURGEON WAS EMBOLIZING THE ANEURYSM, HE FOUND THAT THE COIL DELIVERY ROD WAS BROKEN AND THE COIL COULD NOT BE DELIVERED NORMALLY. IT WAS REPORTED THE PUSHER WAS KINKED/BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS LOCATED ON THE PROXIMAL PUSHWIRE SEGMENT. 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 PUSHER KINK/DAMAGE WAS NOT DETERMINED. THE COIL DELIVERY ROD WAS DAMAGED WHILE IN VITRO. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928659 ↗
• MalfunctionJun 10, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR PERICOLLOSAL ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3.5MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL WAS SECOND TO BE USED IN THE PROCEDURE. THE COIL WAS DELIVERED AS INTENDED. HOWEVER, WHEN THE SURGEON ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER (ID), THE COIL DID NOT DETACH. THE SURGEON THEN ATTEMPTED MANUAL DETACHED VIA THE HYPOTUBE BUT THE COIL STILL DID NOT DETACH. THE COIL WAS THEN REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. IT WAS NOTED THE REPLACEMENT COIL DETACHED SUCCESSFULLY WITHOUT ISSUE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: BALLAST 088 (LOT: F240300135), SL10 MICROCATHETER (LOT: 168190), ARISTOTLE 14 GUIDEWIRE (LOT: 024386).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504447 ↗
• MalfunctionApr 5, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION HAS BEEN RECEIVED. REPORTING, THE CAUSE OF THE PUSHWIRE KINK WAS NOT DETERMINED. THERE WERE NO ISSUES, THAT RESULTED IN THE DAMAGE THAT WAS FOUND. 2 COILS WERE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050716 ↗
• MalfunctionMar 29, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH. THE COIL WAS PUSHED OUT OF MICROCATHETER WITH ANOTHER SUBSEQUENT COIL. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICE AND ANY ACCESSORIES 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 NEUROVASCULAR ABNORMALITIES (NO GRADE). THE ABNORMALITY WAS NOT LOCATED IN THE E LOQUENT REGION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A 6 FR RIST GUIDE CATHETER, HEADWAY DUO 156CM MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004573 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT ANEURYSM EMBOLIZATION CLINICALLY. DURING THE SURGERY, THE AXIUM COIL DID NOT REACH THE ANEURYSM, BUT DETACHED ITSELF. STOPPED USING IT IMMEDIATELY. IT WAS REPORTED THE SPRING COIL FELL OFF AUTOMATICALLY DURING SURGERY. THE INTRACRANIAL STENT FIT RESOLUTE DISLODGEMENT SPRING COIL TO THE ARTERY WALL AND COMPACTED IT, AND THE PROBLEM WAS SOLVED. REPORTED TO SUPERIOR UNIT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911754 ↗
• MalfunctionFeb 15, 2024Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS FOUND STRETCHED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE/STRETCH WAS LOCATED 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. ANCILLARY DEVICES INCLUDE A MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE COIL WAS KINKED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716532 ↗
• MalfunctionNov 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED INTO THE MICROCATHETER. THE AXIUM 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 A SACCULAR, RUPTURED A1 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. IT WAS NOTED THAT COIL RESISTANCE OCCURRED AT THE CATHETER HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049279 ↗
• InjurySep 5, 2023Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE COIL BODY OF THE SPRING DISAPPEARED. 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 ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 3.2MM AND A 1.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A COOK6 SHEATH, NAVIEN MICROCATHETER, ECHELON 10 MICROCATHETER, SYNCHRO2 GUIDEWIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17684547 ↗
• MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY SEGMENT. A 6F LONG SHEATH (COOK) AND INTRACRANIAL SUPPORT CATHETER RFX072-115-08MP WERE USED AS EXTREME SUPPORT. THE ECHELON10 CATHETER WAS PLACED INTO THE CAVITY OF THE ANTERIOR COMMUNICATING ANEURYSM, AND THE DETACHABLE COIL 1.5-3-3D-ES WAS DEPLOYED THROUGH IT. AFTER REPEATEDLY ADJUSTING THE POSITION OF THE SPRING COIL, THE COIL BODY WAS ACCIDENTALLY DETACHED IN THE ECHELON10 MICROCATHETER. THE OPERATOR SAID THAT THE STENT HAD QUALITY PROBLEMS AND ASKED TO REPLACE IT WITH A 1.5-3-3D-ES DETACHABLE COIL. AFTER REPLACING WITH A NEW 1.5-3-3D-ES DETACHABLE COIL, IT WAS SUCCESSFULLY DEPLOYED AND DETACHED.  COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. IT WAS UNKNOWN IF THE PUSHWIRE WAS BENT OR BROKEN OR IF THERE WAS ANY 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 AND CONTINUOUS FLUSH WAS ADMINISTERED. THE REPORTED DEVICE AND ANY ACCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378398 ↗
• MalfunctionMar 13, 2023Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. IT WAS STATED THAT THERE WAS NO NEED FOR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528758 ↗
• MalfunctionAug 17, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE COIL SEPARATED BY ITSELF. USED APB-1.5-3-3D-ES COIL FOR EMBOLIZATION, AFTER THE SURGEON OPENED THE PACKAGE, IN THE PROCESS OF PUSHING THE COIL, THE COIL PUSH ROD WAS SEPARATED FROM THE COIL BY ITSELF. THE COIL REMAINED IN PATIENT. IT IS UNKNOWN IF IT WAS IMPLANTED AT THE INTENDED LOCATION. NO MEDICAL OR SURGICAL INTERVENTION IS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. THEY DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY CAVERNOUS SINUS. THE MAX DIAMETER WAS 6MM ANDTHE NECK DIAMETER WAS 3.5MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT.

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

  MAUDE report 15246234 ↗