Axium Prime Detachable Coil System APB-3-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000313739), received between Jan 13, 2023 and Sep 23, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872675 ↗
• MalfunctionAug 10, 2026Stretched; Material Deformation

  Medtronic received a report of multiple coils that encountered issues with Echelon microcatheters. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the basilar tip with a max diameter of 3mm and a 2mm neck diameter. It was noted the patient's blood flow was normal and the vessel tortuosity was moderate. The access vessel was the femoral artery with a 8mm diameter. No images are available for review. It was reported that the physician used the first Echelon microcatheter (lot D086599) to deliver a 3¿6 coil (lot 232006956). When it was delivered to the proximal end of the introducer sheath, it was observed that the backup detachment point was kinked, and the coil was unintentionally stretched inside the microcatheter. The microcatheter was withdrawn as a whole, and a syringe was used to flush it, pushing the coil out of the catheter. A second new Echelon microcatheter (same lot D086599) was then used instead to deliver an APB¿2¿6¿HX¿ES coil (lot 232006956). However, it became stuck at the microcatheter hub and could not be advanced into the microcatheter. It was replaced with a new 1.5¿2 coil (lot unknown), but it still could not be deliv

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201072 ↗
• MalfunctionMar 12, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE CEREBRAL ARTERY ANEURYSM WAS ENTERED WITH A MICROGUIDE AND AN ECHELON 10-90° PRE-SHAPED TIP MICROCATHETER. THE FIRST COIL WAS SUCCESSFULLY PLACED. WHEN THE SECOND COIL WAS PLACED, IT WOULD NOT PASS THROUGH THE MICROCATHETER. A NEW ECHELON 10-45° MICROCATHETER WAS USED, BUT THE PROBLEM PERSISTED, AND THE COIL WOULD NOT PASS THROUGH. 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 UNDERGOINGCOIL EMBOLIZATION SURGERY FOR TREATMENT OF A MIDDLE CEREBRAL ARTERY ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ARTERIAL ACCESS VESSEL DIAMETER WAS 3 MM. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A 6F INTRODUCER, A CHAPERON DUO CATHETER AND AN AVIGO MICROGUIDE WERE USED. IT WAS CONFIRMED THAT THE COIL DID NOT PASS THROUGH THE MICROCATHETER. IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586998 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE RESISTANCE AND PREMATURE DETACHMENT ISSUE WAS NOT DETERMINED. THE PUSHER WAS KINKED DUE TO ATTEMPTS TO DELIVER AGAINST RESISTANCE. THE SURGEON DID NOT ROTATE THE PUSHWIRE OR PERFORM ANY UNNECESSARY MANEUVERS AND NO ATTEMPT WAS MADE TO DETACH THE COIL. THE COIL DETACHED NEAR THE CATHETER HUB BEFORE ENTERING THE ANEURYSM. THE RESISTANCE OCCURRED IN THE DISTAL END OF THE MICROCATHETER. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS CATHETER HYDRATION WAS PERFORMED. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER AFTER REMOVAL. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT'S BODY AND PUSHED OUT WITH A GUIDEWIRE ON THE SURGICAL TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315928 ↗
• MalfunctionFeb 9, 2026Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT A DETACHABLE COIL APB-3-8-3D-ES WAS DELIVERED USING AN ECHELON 10 MICROCATHETER. THE COIL DID NOT FORM A HOOP WELL WITHIN THE ANEURYSM; THE OPERATOR NOTED THAT THE MIDDLE SEGMENT WAS STRAIGHT AND UNSHAPED, SO IT WAS WITHDRAWN AND DISCARDED. THE OPERATOR THEN REPLACED THE FIRST COIL WITH AN APB-3-6-3D-ES COIL FOR EMBOLIZATION. AFTER COMPLETE FILLING, THE COIL WAS KINKED AND WITHDRAWN, AND DETACHMENT WAS ATTEMPTED WITH THE DETACHMENT WIRE, BUT THE COIL WAS NOT DETACHED. THE ENTIRE COIL WAS RETRIEVED, AND THE SAME MODEL COIL WAS USED TO CONTINUE THE PROCEDURE. AS THE FINAL COIL FOR EMBOLIZATION, UNDER CONTINUOUS DRIP INFUSION, PUSHING THE COIL THROUGH THE ECHELON 10 MICROCATHETER WAS VERY DIFFICULT AND RESISTANT. THE CATHETER WAS WITHDRAWN, AND UPON REMOVAL, IT WAS FOUND THAT THE COIL HAD ALREADY BEEN STRETCHED, WAS NOT IMPLANTED, AND THE TREATMENT WAS CONCLUDED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT MIDDLE CEREBRAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291083 ↗
• MalfunctionNov 24, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS CHARACTERIZED AS AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR CIRCULATION AT THE C5-C6 SEGMENT, MEASURING 5MM BY 4MM. THE CAUSE OF THE COIL NON-DETACHMENT WAS NOT DETERMINED. NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631665 ↗
• MalfunctionNov 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457782 ↗
• MalfunctionOct 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE LESION CHARACTERISTICS WERE ANTERIOR COMMUNICATING ARTERY, APPROXIMATELY 3 MM, RUPTURED ANEURYSM. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. 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 OR CATHETER OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23382836 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, AMORPHOUS ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY AT C6 WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE SURGERY AN AXIUM COIL WAS INSERTED FOR EMBOLIZATION. DURING THE ADJUSTMENT PROCESS, IT WAS FOUND THAT THE AXIUM COIL HAD DETACHED PREMATURELY, SO A NEW AXIUM COIL WAS IMMEDIATELY USED INSTEAD FOR EMBOLIZATION TREATMENT. 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 22770493 ↗
• MalfunctionAug 6, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE DETACHED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730169 ↗
• MalfunctionJul 29, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE, THE INTRODUCTION SHEATH WAS FOUND TO BE KINKED. AFTER REPLACING THE COIL, THE IMPLANT WAS SUCCESSFULLY PERFORMED. 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 ANEURYSM OF THE INTERNAL CAROTID 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 NORMAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER UNPACKING ACCORDING TO NORMAL OPERATION, IT WAS FOUND THAT THE INTRODUCER SHEATH WAS KINKED AND THE CUSTOMER REFUSED TO USE IT. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING WAS FOUND. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640179 ↗
• MalfunctionJul 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL COULD NOT PASS THROUGH THE DISTAL TIP OF THE ECHELON MICROCATHETER. THE TIP OF THE MICROCATHETER WAS DAMAGED. IT WAS NOTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BOTH DEVICES WERE REPLACED TO CONTINUE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE VIA FEMORAL ARTERY ACCESS TO TREAT AN INTERNAL CAROTID ARTERY (ICA) UNRUPTURED SACCULAR ANEURYSM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CAUSE OF THE CATHETER TIP DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527311 ↗
• 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 21985571 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE DELIVERY PROCESS OF THE SPRING COIL, IT WAS FOUND THAT THERE WAS NO IMPLANT AT THE TIP OF THE PUSH ROD, ONLY HAD THE PUSH ROD. 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 A SACCULAR, RUPTURED LEFT POSTERIOR COMMUNICATING SEGMENT ANEURYSM OF THE INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.5 MM AND A 3.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752199 ↗
• MalfunctionMar 3, 2025Separation Failure; Migration; Separation Failure; Migration

  IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY, AFTER THE AXIUM PRIME BARE 3D 3MM X 6CM EXTRA SOFT SPRING COIL WAS PUSHED AND DETACHED, THE PUSH ROD WAS WITHDRAWN AND THE SPRING COIL WAS FOUND TO BE PULLED OUT OF THE ANEURYSM. THE SPRING COIL WAS NOT DETACHED SUCCESSFULLY AND WAS SEPARATED ONLY AFTER REPEATEDLY PUSHING THE PUSH ROD. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 5 MILLIMETERS AND A NECK DIAMETER OF 3.6 MILLIMETERS. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509634 ↗
• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE AXIUM PRIME BARE 3D 3MM X 6CM EXTRA SOFT COIL, THERE WAS A PREMATURE DETACHMENT OF THE COIL. THE COIL WAS REMOVED FROM THE PATIENT USING A MICROCATHETER. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE DEVICE AND ACCESSORY DEVICES, INCLUDING A FUBUKI 8F GUIDE CATHETER, HEADWAY17 MICROCATHETER, AND SYNCHRO14 GUIDEWIRE, WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PRODUCT WAS REPLACED. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061349 ↗
• MalfunctionJul 17, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE DETACHMENT ATTEMPT HAD BEEN MADE EACH WITH THE INSTANT DETACHER AND THE MANUAL METHOD. THERE HAD BEEN NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND NO DAMAGE TO THE PUSHWIRE WAS OBSERVED. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761248 ↗
• MalfunctionJun 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL ENCOUNTERED RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3.4MM AND A 1.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT FOR LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, DURING THE OPERATION, THE STENT WAS FIRST PLACED AND THEN FILLED THE COIL. WHEN FILLING THE COIL, APB-3-6-3D-ES WAS SELECTED AS THE FIRST COIL. THERE WAS NO ABNORMAL HYDRATION AND THE PUSHING RESISTANCE WAS EXTREMELY HIGH. THEN, THEY WITHDREW THE MICROCATHETER AND COIL, PULLED OUT THE ABNORMAL COIL, AND OPERATED AGAIN OUTSIDE THE BODY. THE PUSH RESISTANCE REMAINED THE SAME. THE MESH WAS RE-PIERCED FOR FILLING, AND APB-2.5-4-3D-ES WAS RE-SELECTED FOR EMBOLIZATION. THE OPERATION WENT SMOOTHLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED DURING PREPARATION, THE INTRODUCER SHEATH HELD VERTICALLY WHEN THE IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607721 ↗
• MalfunctionNov 8, 2023Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE TO PACKAGING AND THE PACKAGE WAS INTACT. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094136 ↗
• MalfunctionApr 10, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD BROKEN IN THE CATHETER AND A ECHELON CATHETER HAD KICKBACK. FEMORAL ACCESS, NEURON MAX 90CM NAVIEN 105CM 072, ECHELON 10 PLACED IN ANEURYSM AND INITIALLY A 4 X 12 AXIUM TRIED WHICH WAS TOO BIG, 3 X 6 TAKEN AND FIRST COUPLE OF LOOPS PLACED WITHIN ANEURYSM TO NOTE, P1 HAS FENESTRATION DISTAL TO ANEURYSMS AND STENOSIS IMMEDIATELY DISTAL TO LARGER ANEURYSM WHICH CAUSED DIFFICULTY INITIALLY TRACKING PAST THE ANEURYSM TOWARDS THE P2 SEGMENT PHENOM 21 150CM TAKEN TO RP2, AFTER SOME DIFFICULTY AND CHANGING GUIDE WIRE ECHELON JAILED IN ANEURYSM CASE MADE MORE CHALLENGING AS SINGLE PLANE ONLY AVAILABLE (BIPLANE MACHINE DOWN) SO DIFFICULT TO SEE THE SMALL ANEURYSM TO NEGOTIATE PAST SIM AND SIZE USED 2.50 X 14 PLACED WITH LITTLE DIFFICULTY UP UNTIL HALFWAY ACROSS THE ANEURYSM NECK, SOME INTERPLAY BETWEEN THE STENT AND ECHELON 10 WHICH STARTED TO BACK OUT AND COIL BACKED OUT TO SOME DEGREE, PHYSICIAN ATTEMPTED TO REPLACE COIL AND THEN CATHETER BUT COIL WOULD NOT RESPOND, HE STATED THAT THE COIL HAD BROKEN, HE FELT IT BREAK WITHIN THE CATHETER. HE MANAGED TO RETRIEVE BOTH THE COIL AND CATHETER TOGETHER WHICH HAVE BEEN RETAINED UNTOUCHED FOR E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709793 ↗
• MalfunctionMar 23, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE LEFT ANTERIOR COMMUNICATING ARTERY M1 WITH A MAX DIAMETER OF 4 MM AND A 2.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON PERFORMED AN ANEURYSM EMBOLIZATION. THE FIRST COIL WAS SELECTED APB-3-8-3D FOR EMBOLIZATION, AND APB-3-6-3D WAS SELECTED FOR THE SECOND COIL, WHICH COULD NOT BE PUSHED OUT. REPLACED IT WITH 3-6-2D, THE EMBOLIZATION WAS SMOOTH. APB-2-4-2D WAS SELECTED FOR THE THIRD COIL. APB-1.5-3-2D WAS CHOSEN FOR FORTH COIL AND THE EMBOLIZATION WAS SMOOTH. SO COMPLAINED ABOUT THE SPRING COIL THAT COULD NOT BE PUSHED OUT. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN SHEATH. 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 IT WAS UNKNOWN IF THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598957 ↗
• MalfunctionFeb 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MICROCATHETER LOT NUMBER WAS B384077.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334340 ↗
• MalfunctionJan 13, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT, NO ISSUES HAD BEEN ENCOUNTERED. IT WAS UNKNOWN IF THERE WAS ANY PUSHWIRE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156846 ↗